One Lung VentilationNCT05851612
Comparison of Three Methods of PEEP Titration During One Lung Ventilation in Prone Position
A study testing constant PEEP, Driving pressure guided PEEP and oxygenation method guided PEEP in people with One Lung Ventilation, run by Mansoura University at 1 site in Egypt.
Trial summary
One-lung ventilation and prone positioning during thoracoscopic esophagectomy is associated with pulmonary complications so lung protection is strongly recommended. Individualization the optimal PEEP level according to the respira¬tory condition of patients has gradually attracted the attention of clinicians. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- One Lung Ventilation
- What is being tested?
- constant PEEP, Driving pressure guided PEEP and oxygenation method guided PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2023to 21 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) (grade 1or 2) patients.
- Scheduled for elective thoracoscopic esophagectomy treated with one lung ventilation in prone position and surgery of expected duration greater than 1 h.
- Body mass index (BMI) less than 30 kg/m2.
Who cannot join
- Patient's refusal.
- Altered mental status or un-cooperative patients.
- History of known sensitivity to the used anesthetics.
- Significant cardiac dysfunction, hepatic, or renal impairment.
- History of severe chronic obstructive pulmonary disease.
- History of severe or uncontrolled bronchial asthma.
Show all 10Show fewer
- History of severe restrictive lung disease.
- History of pulmonary metastases.
- History of any thoracic surgery.
- Need for chest drainage prior to surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of PEEP Titration Guided by Driving Pressure Versus Oxygenation Method Versus Constant PEEP in Patients Undergoing Esophagectomy With One Lung Ventilation in Prone Position
One-lung ventilation and prone positioning during thoracoscopic esophagectomy is associated with pulmonary complications so lung protection is strongly recommended. Individualization the optimal PEEP level according to the respira¬tory condition of patients has gradually attracted the attention of clinicians. The aim of this study is to compare and evaluate the differences between three different PEEP values in patients who will undergo thoracoscopic esophagectomy receiving either constant PEEP or driving pressure guided individualized PEEP or oxygenation guided individualized PEEP.
Read the detailed description
Induction of general anesthesia and mechanical ventilation impair respiratory function because of alveoli collapse, decreased functional residual capacity, diminished arterial oxygenation, and even mechanical ventilation-induced injury.In addition, One-lung ventilation during thoracic surgery is prone to ventilator induced lung injury and oxygen toxicity. It is also associated with a profound inflammatory cytokine release which causes excessive neutrophils recruitment that increases pulmonary vascular permeability in both lungs. These reactions often precede systemic inflammatory response syndrome, acute respiratory distress syndrome and pneumonia. Therefore, lung protection and protective ventilation is strongly recommended during thoracic surgery.In contrast to the lateral decubitus position, OLV in the prone position is devoid of the beneficial effect of gravity on preferential redistribution of the pulmonary blood flow to the dependent areas of a lung, possibly resulting in increased V/Q mismatch. Also, the prone position is frequently associated with decreased respiratory compliance and increased peak airway pressure in anesthetized and paralyzed patients when not assuring free abdominal and chest movements, which is further aggravated by CO2 insufflation. Prone positioning during esophagectomy provides several advantages, including shortened operative times and superior surgical view, at the cost of one-lung ventilation (OLV). Intraoperative lung protective ventilation strategy, which includes the combination of low tidal volume and adequate PEEP levels during operation, has been reported to improve respiratory mechanics and reduce the incidence and severity of atelectasis which may prolong hospital stays and increase mortality in surgical patients.Improper PEEP levels have an impact on patient physiology. If the setting level is too low to achieve the desired purpose, it cannot produce the effect of applying PEEP. If the setting level is too high, the pulmonary vascular resistance increases, venous return blood volume decreases, intrapulmonary shunt increases, and arterial oxygen partial pressure level is reduced. Also, it could negatively affect cardiac output and delivery of oxygen to vital organs.Individualization the optimal PEEP level according to the respira¬tory condition of patients has gradually attracted the attention of clinicians. The methods to determine the best PEEP levels include computed tomography scanning, electri¬cal impedance tomography, ultrasound, P-V curve method, best oxygenation titration method, and best lung compliance titration method. Each method has its advantages and disadvantages. Individualized PEEP has advantages over fixed PEEP in improved respiratory mechanics and prevent progressive alveolar collapse.There are few studies on the selection of appropriate PEEP values during one-lung ven¬tilation (OLV) in prone position and the protective effect of PEEP values can be titrated by different titration methods which still requires many prospective studies. Therefore, this study will be conducted to compare PEEP titration using driving pressure versus oxygenation method versus constant PEEP and evaluate their efficacy on oxygenation, ventilation, hemodynamics and PPC for patients undergoing thoracoscopic esophagectomy treated with one lung ventilation in prone position.
Aim of the Study:
The aim of this study is to compare and evaluate the differences between three different PEEP values in patients who will undergo thoracoscopic esophagectomy treated with one lung ventilation in prone position receiving either constant PEEP or driving pressure guided individualized PEEP or oxygenation guided individualized PEEP.
It is hypothesized that the individualized PEEP guided by driving pressure could improve intraoperative oxygenation function, pulmonary mechanics, early postoperative atelectasis, and reduce the incidence of postoperative pulmonary complications(PPCs) for patients undergoing thoracoscopic esophagectomy treated with one lung ventilation in prone position.
Sample Size Calculation:
A pilot study was performed to measure the lung ultrasound score at the end of the surgery to estimate the sample size. Sample size calculations were performed using G. power software (version 3.1.9.7). The means and standard deviations for the D group, O group, and C group were 10.5 + 2.02, 11.7 + 1.2, and 12.5 + 2.5, respectively. Sample size calculations showed that 11 subjects per group will be required to achieve 95% power with a Type I error of 0.05. A total of 42 patients (14 patients per group) will be included in this trial considering an 80% adherence rate.
Methods:
The study will include 42 patients who will be scheduled for thoracoscopic esophagectomy treated with one lung ventilation in prone position under general anesthesia. It will be conducted in Mansoura gastroenterology center over one year and patients will be recruited in june 2023. they will be randomly assigned to 3 equal groups (D group, O group and C group) according to computer-generated table of random numbers using the permuted block randomization method. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes which will be opened only after obtaining the written informed consent.A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation and set up the ventilator as specified in the envelope. The study subjects and the resident assessing the outcome will be blinded to the study group.The study protocol will be explained to all patients after enrollment into the study. They will be kept fasting according to pre-operative ASA recommendations prior to surgery. Basic demographic characters including age, sex, and BMI will be recorded. The peri-operative management will be identical in the three groups.
Statistical analysis:- The collected data will be coded, processed, and analyzed using Statistical Package for the Social Sciences (SPSS) program (version 22) for Windows. Normality of numerical data distribution will be tested by Kolmogorov-Smirnov test. Normally distributed numerical data will be presented as mean and standard deviation, and their comparison in different groups will be performed using one-way ANOVA with post-hoc Bonferroni test. Non-normally distributed numerical data will be presented as median and range, and compared nonparametrically using Kruskal-Wallis test followed by Mann-Whitney U test. Categorical data will be presented as number and percentage, and their comparison will be performed using Chi-square test. The all data will be considered significant if P value is ≤ 0.05.
- Conditions
- One Lung Ventilation
- Being tested
- constant PEEP, Driving pressure guided PEEP, oxygenation method guided PEEP
- Keywords
- optimal PEEP -one lung ventilation-prone position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
constant PEEPProcedure or surgery
Constant PEEP of 5 cm H2O will be applied and maintained throughout one-lung ventilation.
Driving pressure guided PEEPProcedure or surgery
PEEP titration will be started at 5 cmH2O and then increased in 1 cmH2O interval to 10 cmH2O. After 10 breath cycles will maintained, Driving pressure (ΔP) will be measured at each PEEP level at the last cycle. The PEEP indicating the lowest ΔP will be selected if multiple levels of PEEP showed the same lowest ΔP, the lowest PEEP will be selected. Driving pressure will be calculated as plateau pressure minus PEEP. Titration will stopped if peak inspiratory pressure of 50 cm H2O, or plateau pressure of 40 cm H2O reached, or hypotension will be observed.
oxygenation method guided PEEPProcedure or surgery
PEEP titration will be started from 5 cmH2O and increase of 1 cmH2O every 4 min with fixed driving pressure that will result in delivery of a fixed tidal volume (TV) of 6ml/kg ideal body weight (IBW). Optimal PEEP will be defined as the PEEP below which PaO2 /FIO2 falls by at least 20%. If at least 20% PaO2 /FIO2 decrement is not obtained, then PEEP that will result in the highest PaO2 will be selected.
| Study group | Role | What they receive |
|---|---|---|
| group C(constant group) | Active comparator | Constant PEEP of 5 centimeter of water (cm H2O) will be applied Receives: Procedure: constant PEEP |
| group D (driving group) | Active comparator | PEEP titration will be according to driving pressure Receives: Procedure: Driving pressure guided PEEP |
| group O (oxygenation group) | Active comparator | PEEP titration will be according to oxygenation method Receives: Procedure: oxygenation method guided PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultrasound score
Thorax will be divided into 12 segments. The lung ultrasound score is 0 to 3, based on the B-line count and the degree of subpleural solidity. A total score of 0-36 will be obtained by summing the scores of the 12 segments. The absolute difference in the three lung ultrasound scores measured before induction, before neuromuscular block reversal, at the end of surgery/before extubation, and 5 min before leaving the PACU respectively.
Measured: Up to 5 min before leaving the post anesthesia care unit (PACU)
Secondary outcomes (23)
Positive end-expiratory pressure (PEEP)
It will be collected at 10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
The ratio of partial pressure of oxygen in arterial blood to the fraction of inspiratory oxygen concentration (PaO2/FiO2 ratio)
It will be collected at before induction ,10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
Heart rate (HR)
It will be recorded before the procedure, after 15 min, 30 minutes and then every 30min intraoperative till the end of surgery.
Measured: Up to the end of the procedure
The Central venous pressure (CVP) values
It will be recorded before the procedure, after 15 min, 30 minutes and then every 30min intraoperative till the end of surgery.
Measured: Up to the end of the procedure
The total volume of fluids and vasopressors administered
They will be recorded at the end of surgery
Measured: Up to the end of the procedure
The duration of operation, anesthesia and one lung ventilation .
will be recorded at the end of surgery
Measured: Up to the end of the procedure
Occurrence of Intra-operative adverse effects
Any adverse events occur intraoperative as hypotension or bradycardia will be recorded.
Measured: Up to the end of the procedure
Plateau pressure
It will be collected at 10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
Driving pressure
It will be collected at 10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
Tidal volume
It will be collected at 10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
Static compliance
It will be collected at 10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
Peak pressure
It will be collected at 10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
End-tidal carbon dioxide
It will be collected at 10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
Oxygen saturation
It will be collected at 10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
The alveolar-arterial gradient (A-a gradient)
It will be collected at 10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
the potential of hydrogen (pH)
It will be collected at before induction ,10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
The partial pressure of carbon dioxide in arterial blood(PaCO2)
It will be collected at before induction ,10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
the partial pressure of oxygen n arterial blood(PaO2)
It will be collected at before induction ,10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
Actual base excess
It will be collected at before induction ,10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
Bicarbonate (HCO3)
It will be collected at before induction ,10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
Lactate
It will be collected at before induction ,10 minutes after induction, Prone position, 10 minutes after titration and every hour until the end of OLV, before neuromuscular block reversal and at the end of surgery/before extubation.
Measured: Up to the end of the procedure
Mean arterial blood pressure (MAP)
It will be recorded before the procedure, after 15 min, 30 minutes and then every 30min intraoperative till the end of surgery.
Measured: Up to the end of the procedure
Occurrence of post-operative complications.
the occurrence of PPC (cough, increased sputum, dyspnea, chest pain, temperature above 38 °C, HR > 100 beats/min) will be recorded.
Measured: up to one week after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start5 Jun 2023
- Primary completion10 Oct 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for One Lung VentilationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Hazem abdelmaksood EL-deeb, Mansoura University
- Investigators
- Amany EL-Deeb, MD, Principal investigator, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851612
- Sponsor's protocol ID
- PEEP in OLV in prone position
- Status last verified
- Nov 2024
- First submitted
- 14 Apr 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Choi YS, Shim JK, Na S, Hong SB, Hong YW, Oh YJ. Pressure-controlled versus volume-controlled ventilation during one-lung ventilation in the prone position for robot-assisted esophagectomy. Surg Endosc. 2009 Oct;23(10):2286-91. doi: 10.1007/s00464-008-0310-5. Epub 2009 Jan 30.
PubMed 19184209Wang ZY, Ye SS, Fan Y, Shi CY, Wu HF, Miao CH, Zhou D. Individualized positive end-expiratory pressure with and without recruitment maneuvers in obese patients during bariatric surgery. Kaohsiung J Med Sci. 2022 Sep;38(9):858-868. doi: 10.1002/kjm2.12576. Epub 2022 Jul 22.
PubMed 35866347Park M, Ahn HJ, Kim JA, Yang M, Heo BY, Choi JW, Kim YR, Lee SH, Jeong H, Choi SJ, Song IS. Driving Pressure during Thoracic Surgery: A Randomized Clinical Trial. Anesthesiology. 2019 Mar;130(3):385-393. doi: 10.1097/ALN.0000000000002600.
PubMed 30664548Yao W, Yang B, Wang W, Han Q, Liu F, Shan S, Wang C, Zheng M. Effect of Positive End-Expiratory Pressure (PEEP) Titration in Elderly Patients Undergoing Lobectomy. Med Sci Monit. 2022 Dec 13;28:e938225. doi: 10.12659/MSM.938225.
PubMed 36510453Liu K, Huang C, Xu M, Wu J, Frerichs I, Moeller K, Zhao Z. PEEP guided by electrical impedance tomography during one-lung ventilation in elderly patients undergoing thoracoscopic surgery. Ann Transl Med. 2019 Dec;7(23):757. doi: 10.21037/atm.2019.11.95.
PubMed 32042773Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.
PubMed 27669555Xu Q, Guo X, Liu J, Li SX, Ma HR, Wang FX, Lin JY. Effects of dynamic individualized PEEP guided by driving pressure in laparoscopic surgery on postoperative atelectasis in elderly patients: a prospective randomized controlled trial. BMC Anesthesiol. 2022 Mar 16;22(1):72. doi: 10.1186/s12871-022-01613-9.
PubMed 35296253
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PEEP Titration Guided by Driving Pressure Versus Oxygenation Method Versus Constant PEEP in Patients Undergoing Esophagectomy With One Lung Ventilation in Prone Position
- ClinicalTrials.gov ID
- NCT05851612
- Acronym / sponsor ID
- PEEP in OLV in prone position
- Conditions
- One Lung Ventilation
- Keywords
- optimal PEEP -one lung ventilation-prone position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One-lung ventilation and prone positioning during thoracoscopic esophagectomy is associated with pulmonary complications so lung protection is strongly recommended. Individualization the optimal PEEP level according to the respira¬tory condition of patients has gradually attracted the attention of clinicians. The aim of this study is to compare and evaluate the differences between three different PEEP values in patients who will undergo thoracoscopic esophagectomy receiving either constant PEEP or driving pressure guided individualized PEEP or oxygenation guided individualized PEEP.
Detailed description
Induction of general anesthesia and mechanical ventilation impair respiratory function because of alveoli collapse, decreased functional residual capacity, diminished arterial oxygenation, and even mechanical ventilation-induced injury.In addition, One-lung ventilation during thoracic surgery is prone to ventilator induced lung injury and oxygen toxicity. It is also associated with a profound inflammatory cytokine release which causes excessive neutrophils recruitment that increases pulmonary vascular permeability in both lungs. These reactions often precede systemic inflammatory response syndrome, acute respiratory distress syndrome and pneumonia. Therefore, lung protection and protective ventilation is strongly recommended during thoracic surgery.In contrast to the lateral decubitus position, OLV in the prone position is devoid of the beneficial effect of gravity on preferential redistribution of the pulmonary blood flow to the dependent areas of a lung, possibly resulting in increased V/Q mismatch. Also, the prone position is frequently associated with decreased respiratory compliance and increased peak airway pressure in anesthetized and paralyzed patients when not assuring free abdominal and chest movements, which is further aggravated by CO2 insufflation. Prone positioning during esophagectomy provides several advantages, including shortened operative times and superior surgical view, at the cost of one-lung ventilation (OLV). Intraoperative lung protective ventilation strategy, which includes the combination of low tidal volume and adequate PEEP levels during operation, has been reported to improve respiratory mechanics and reduce the incidence and severity of atelectasis which may prolong hospital stays and increase mortality in surgical patients.Improper PEEP levels have an impact on patient physiology. If the setting level is too low to achieve the desired purpose, it cannot produce the effect of applying PEEP. If the setting level is too high, the pulmonary vascular resistance increases, venous return blood volume decreases, intrapulmonary shunt increases, and arterial oxygen partial pressure level is reduced. Also, it could negatively affect cardiac output and delivery of oxygen to vital organs.Individualization the optimal PEEP level according to the respira¬tory condition of patients has gradually attracted the attention of clinicians. The methods to determine the best PEEP levels include computed tomography scanning, electri¬cal impedance tomography, ultrasound, P-V curve method, best oxygenation titration method, and best lung compliance titration method. Each method has its advantages and disadvantages. Individualized PEEP has advantages over fixed PEEP in improved respiratory mechanics and prevent progressive alveolar collapse.There are few studies on the selection of appropriate PEEP values during one-lung ven¬tilation (OLV) in prone position and the protective effect of PEEP values can be titrated by different titration methods which still requires many prospective studies. Therefore, this study will be conducted to compare PEEP titration using driving pressure versus oxygenation method versus constant PEEP and evaluate their efficacy on oxygenation, ventilation, hemodynamics and PPC for patients undergoing thoracoscopic esophagectomy treated with one lung ventilation in prone position.
Aim of the Study:
The aim of this study is to compare and evaluate the differences between three different PEEP values in patients who will undergo thoracoscopic esophagectomy treated with one lung ventilation in prone position receiving either constant PEEP or driving pressure guided individualized PEEP or oxygenation guided individualized PEEP.
It is hypothesized that the individualized PEEP guided by driving pressure could improve intraoperative oxygenation function, pulmonary mechanics, early postoperative atelectasis, and reduce the incidence of postoperative pulmonary complications(PPCs) for patients undergoing thoracoscopic esophagectomy treated with one lung ventilation in prone position.
Sample Size Calculation:
A pilot study was performed to measure the lung ultrasound score at the end of the surgery to estimate the sample size. Sample size calculations were performed using G. power software (version 3.1.9.7). The means and standard deviations for the D group, O group, and C group were 10.5 + 2.02, 11.7 + 1.2, and 12.5 + 2.5, respectively. Sample size calculations showed that 11 subjects per group will be required to achieve 95% power with a Type I error of 0.05. A total of 42 patients (14 patients per group) will be included in this trial considering an 80% adherence rate.
Methods:
The study will include 42 patients who will be scheduled for thoracoscopic esophagectomy treated with one lung ventilation in prone position under general anesthesia. It will be conducted in Mansoura gastroenterology center over one year and patients will be recruited in june 2023. they will be randomly assigned to 3 equal groups (D group, O group and C group) according to computer-generated table of random numbers using the permuted block randomization method. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes which will be opened only after obtaining the written informed consent.A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation and set up the ventilator as specified in the envelope. The study subjects and the resident assessing the outcome will be blinded to the study group.The study protocol will be explained to all patients after enrollment into the study. They will be kept fasting according to pre-operative ASA recommendations prior to surgery. Basic demographic characters including age, sex, and BMI will be recorded. The peri-operative management will be identical in the three groups.
Statistical analysis:- The collected data will be coded, processed, and analyzed using Statistical Package for the Social Sciences (SPSS) program (version 22) for Windows. Normality of numerical data distribution will be tested by Kolmogorov-Smirnov test. Normally distributed numerical data will be presented as mean and standard deviation, and their comparison in different groups will be performed using one-way ANOVA with post-hoc Bonferroni test. Non-normally distributed numerical data will be presented as median and range, and compared nonparametrically using Kruskal-Wallis test followed by Mann-Whitney U test. Categorical data will be presented as number and percentage, and their comparison will be performed using Chi-square test. The all data will be considered significant if P value is ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, double blind study
| Arm | Type | Receives |
|---|---|---|
| group C(constant group) | Active comparator | Procedure: constant PEEPConstant PEEP of 5 centimeter of water (cm H2O) will be applied |
| group D (driving group) | Active comparator | Procedure: Driving pressure guided PEEPPEEP titration will be according to driving pressure |
| group O (oxygenation group) | Active comparator | Procedure: oxygenation method guided PEEPPEEP titration will be according to oxygenation method |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology (ASA) (grade 1or 2) patients.
- Scheduled for elective thoracoscopic esophagectomy treated with one lung ventilation in prone position and surgery of expected duration greater than 1 h.
- Body mass index (BMI) less than 30 kg/m2.
Key exclusion criteria (10 listed)
- Patient's refusal.
- Altered mental status or un-cooperative patients.
- History of known sensitivity to the used anesthetics.
- Significant cardiac dysfunction, hepatic, or renal impairment.
- History of severe chronic obstructive pulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| constant PEEPConstant PEEP of 5 cm H2O will be applied and maintained throughout one-lung ventilation. | Procedure or surgery | group C(constant group) |
| Driving pressure guided PEEPPEEP titration will be started at 5 cmH2O and then increased in 1 cmH2O interval to 10 cmH2O. After 10 breath cycles will maintained, Driving pressure (ΔP) will be measured at each PEEP level at the last cycle. The PEEP indicating the lowest ΔP will be selected if multiple levels of PEEP showed the same lowest ΔP, the lowest PEEP will be selected. Driving pressure will be calculated as plateau pressure minus PEEP. Titration will stopped if peak inspiratory pressure of 50 cm H2O, or plateau pressure of 40 cm H2O reached, or hypotension will be observed. | Procedure or surgery | group D (driving group) |
| oxygenation method guided PEEPPEEP titration will be started from 5 cmH2O and increase of 1 cmH2O every 4 min with fixed driving pressure that will result in delivery of a fixed tidal volume (TV) of 6ml/kg ideal body weight (IBW). Optimal PEEP will be defined as the PEEP below which PaO2 /FIO2 falls by at least 20%. If at least 20% PaO2 /FIO2 decrement is not obtained, then PEEP that will result in the highest PaO2 will be selected. | Procedure or surgery | group O (oxygenation group) |
Primary outcome
lung ultrasound score
Time frame: Up to 5 min before leaving the post anesthesia care unit (PACU)
Thorax will be divided into 12 segments. The lung ultrasound score is 0 to 3, based on the B-line count and the degree of subpleural solidity. A total score of 0-36 will be obtained by summing the scores of the 12 segments. The absolute difference in the three lung ultrasound scores measured before induction, before neuromuscular block reversal, at the end of surgery/before extubation, and 5 min before leaving the PACU respectively.
23 secondary outcomes
Positive end-expiratory pressure (PEEP)
Time frame: Up to the end of the procedure
The ratio of partial pressure of oxygen in arterial blood to the fraction of inspiratory oxygen concentration (PaO2/FiO2 ratio)
Time frame: Up to the end of the procedure
Heart rate (HR)
Time frame: Up to the end of the procedure
The Central venous pressure (CVP) values
Time frame: Up to the end of the procedure
The total volume of fluids and vasopressors administered
Time frame: Up to the end of the procedure
The duration of operation, anesthesia and one lung ventilation .
Time frame: Up to the end of the procedure
Occurrence of Intra-operative adverse effects
Time frame: Up to the end of the procedure
Plateau pressure
Time frame: Up to the end of the procedure
Driving pressure
Time frame: Up to the end of the procedure
Tidal volume
Time frame: Up to the end of the procedure
Static compliance
Time frame: Up to the end of the procedure
Peak pressure
Time frame: Up to the end of the procedure
End-tidal carbon dioxide
Time frame: Up to the end of the procedure
Oxygen saturation
Time frame: Up to the end of the procedure
The alveolar-arterial gradient (A-a gradient)
Time frame: Up to the end of the procedure
the potential of hydrogen (pH)
Time frame: Up to the end of the procedure
The partial pressure of carbon dioxide in arterial blood(PaCO2)
Time frame: Up to the end of the procedure
the partial pressure of oxygen n arterial blood(PaO2)
Time frame: Up to the end of the procedure
Actual base excess
Time frame: Up to the end of the procedure
Bicarbonate (HCO3)
Time frame: Up to the end of the procedure
Lactate
Time frame: Up to the end of the procedure
Mean arterial blood pressure (MAP)
Time frame: Up to the end of the procedure
Occurrence of post-operative complications.
Time frame: up to one week after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Results publication: PubMed 19184209Choi YS, Shim JK, Na S, Hong SB, Hong YW, Oh YJ. Pressure-controlled versus volume-controlled ventilation during one-lung ventilation in the prone position for robot-assisted esophagectomy. Surg Endosc. 2009 Oct;23(10):2286-91. doi: 10.1007/s00464-008-0310-5. Epub 2009 Jan 30.
- Results publication: PubMed 35866347Wang ZY, Ye SS, Fan Y, Shi CY, Wu HF, Miao CH, Zhou D. Individualized positive end-expiratory pressure with and without recruitment maneuvers in obese patients during bariatric surgery. Kaohsiung J Med Sci. 2022 Sep;38(9):858-868. doi: 10.1002/kjm2.12576. Epub 2022 Jul 22.
- Results publication: PubMed 30664548Park M, Ahn HJ, Kim JA, Yang M, Heo BY, Choi JW, Kim YR, Lee SH, Jeong H, Choi SJ, Song IS. Driving Pressure during Thoracic Surgery: A Randomized Clinical Trial. Anesthesiology. 2019 Mar;130(3):385-393. doi: 10.1097/ALN.0000000000002600.
- Results publication: PubMed 36510453Yao W, Yang B, Wang W, Han Q, Liu F, Shan S, Wang C, Zheng M. Effect of Positive End-Expiratory Pressure (PEEP) Titration in Elderly Patients Undergoing Lobectomy. Med Sci Monit. 2022 Dec 13;28:e938225. doi: 10.12659/MSM.938225.
- Results publication: PubMed 32042773Liu K, Huang C, Xu M, Wu J, Frerichs I, Moeller K, Zhao Z. PEEP guided by electrical impedance tomography during one-lung ventilation in elderly patients undergoing thoracoscopic surgery. Ann Transl Med. 2019 Dec;7(23):757. doi: 10.21037/atm.2019.11.95.
- Results publication: PubMed 27669555Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.
- Results publication: PubMed 35296253Xu Q, Guo X, Liu J, Li SX, Ma HR, Wang FX, Lin JY. Effects of dynamic individualized PEEP guided by driving pressure in laparoscopic surgery on postoperative atelectasis in elderly patients: a prospective randomized controlled trial. BMC Anesthesiol. 2022 Mar 16;22(1):72. doi: 10.1186/s12871-022-01613-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amany EL-Deeb, MD principal investigator
Faculty of Medicine, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing constant PEEP, Driving pressure guided PEEP and oxygenation method guided PEEP in people with One Lung Ventilation, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung ultrasound score (time frame: Up to 5 min before leaving the post anesthesia care unit (PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851612, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.