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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Mansoura University

    Al Mansurah, 35511

Other trials in Egypt

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.

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 groups in NCT05851612
Study groupRoleWhat they receive
group C(constant group)Active comparatorConstant PEEP of 5 centimeter of water (cm H2O) will be applied
Receives: Procedure: constant PEEP
group D (driving group)Active comparatorPEEP titration will be according to driving pressure
Receives: Procedure: Driving pressure guided PEEP
group O (oxygenation group)Active comparatorPEEP 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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.

  1. First posted9 May 2023
  2. Study start5 Jun 2023
  3. Primary completion10 Oct 2024
  4. Study completion21 Nov 2024

Resources

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)
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 19184209
  • Wang 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 35866347
  • Park 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 30664548
  • Yao 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 36510453
  • Liu 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 32042773
  • Monastesse 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 27669555
  • Xu 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

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.

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