Positive End-expiratory PressureNCT06115668
Individualized Positive End-Expiratory Pressure (PEEP) on Oxygenation, Hemodynamics, and Early Postoperative Atelectasis in Laparoscopic Bariatric Surgery
A study testing Positive end-expiratory pressure 5 (PEEP 5) and Individualized positive end-expiratory pressure (PEEPIND) in people with Positive End-expiratory Pressure and Hemodynamic Variable, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effectiveness of intraoperative individualized positive end-expiratory pressure (PEEPIND) titration, compared to fixed positive end-expiratory pressure of 5 cmH2O, on oxygenation, hemodynamic variables, and early postoperative complications in obese patients undergoing… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Positive End-expiratory Pressure, Hemodynamic Variable, Postoperative Atelectasis
- What is being tested?
- Positive end-expiratory pressure 5 (PEEP 5) and Individualized positive end-expiratory pressure (PEEPIND)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2023to 1 Apr 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 21 to 60 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status class I-III
- Patients who are scheduled for elective laparoscopic bariatric surgery under general anesthesia.
Who cannot join
- Patients who are unwilling to participate in the study
- Actively smokers.
- Patients who had a history of Chronic obstructive pulmonary disease or bronchial asthma.
- Patients who are receiving renal replacement therapy prior to surgery.
- Patients who had a history of heart failure.
- Pregnant.
- Patients who have allergies to any drug used in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Heba Z Khattab, 00201004774825, hebazakaria194@gmail.com
Ahmed M El-Sheikh, MD
About this study
Official title: Effects of Individualized Positive End-Expiratory Pressure (PEEP) on Oxygenation, Hemodynamic Variables, and Incidence of Early Postoperative Atelectasis in Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Controlled Study
The aim of this study is to evaluate the effectiveness of intraoperative individualized positive end-expiratory pressure (PEEPIND) titration, compared to fixed positive end-expiratory pressure of 5 cmH2O, on oxygenation, hemodynamic variables, and early postoperative complications in obese patients undergoing laparoscopic bariatric surgery.
Read the detailed description
Obesity is a major health problem, and the incidence is increasing worldwide. So far, the only treatment for morbid obesity with good long-term results is bariatric surgery.
Obese patients have unique respiratory physiology and ventilatory mechanics characteristics. Their lung function is impaired due to the reduction of oxygen reserve, functional residual capacity, and lung compliance. In addition, they frequently present with respiratory comorbidities, which increases the risk of developing postoperative pulmonary complications (PPCs) such as atelectasis especially after procedures under general anesthesia. Atelectasis has been hypothesized as a main cause of postoperative hypoxemia.
To reduce the incidence of atelectasis, positive end-expiratory pressure (PEEP) and recruitment maneuvers are used as a protective lung strategy to improve gas exchange and lung mechanics through reopening collapsed alveoli and maintaining the aeration of lungs. Application of PEEP may also eliminate auto-PEEP without increasing plateau pressure.
- Conditions
- Positive End-expiratory Pressure, Hemodynamic Variable, Postoperative Atelectasis, Laparoscopic Bariatric Surgery
- Being tested
- Positive end-expiratory pressure 5 (PEEP 5), Individualized positive end-expiratory pressure (PEEPIND)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive end-expiratory pressure 5 (PEEP 5)Other
Fixed positive end-expiratory pressure of 5 cmH2O will be maintained throughout the duration of surgery
Individualized positive end-expiratory pressure (PEEPIND)Other
Patients will receive the individualized positive end-expiratory pressure. Titration process will be started after establishment of pneumoperitoneum: setting the initial PEEP to 5 cmH2O, then increasing positive end-expiratory pressure (PEEP)according to the gradient of 2 cmH2O every 3 min, calculating static compliance (Cstat) according to the formula: [Cstat = VT/Pplat - PEEP] (Pplat = plateau pressure), then gradually increasing positive end-expiratory pressure , until the calculated Cstat shows a downward trend, set its previous PEEP (corresponding to PEEP for high Cstat) as the optimal PEEPIND for this patient. The highest PEEP is limited to 20 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| Positive end-expiratory pressure 5 (PEEP 5) | Active comparator | Patients will receive fixed positive end-expiratory pressure(= 5 cmH2O) as a control group Receives: Other: Positive end-expiratory pressure 5 (PEEP 5) |
| Individualized positive end-expiratory pressure (PEEPIND) | Experimental | Patients who will receive the individualized positive end-expiratory pressure. Receives: Other: Individualized positive end-expiratory pressure (PEEPIND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative oxygenation
Intraoperative oxygenation which will be assessed by P/F ratio (the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
PaO2/FiO2: will be measured at before induction of anesthesia, immediately after intubation, after PEEP titration, one hour after pneumoperitoneum, before extubation, one hour after extubation
Measured: One hour after extubation
Secondary outcomes (7)
Mean arterial pressure(MAP)
Mean arterial pressure will be measured before induction of anesthesia, immediately after intubation, after positive End-Expiratory Pressure titration, one hour after pneumoperitoneum, before extubation, and one hour after extubation.
Measured: One hour after extubation
Heart rate(HR)
Heart rate will be measured before induction of anesthesia, immediately after intubation, after positive End-Expiratory Pressure titration, one hour after pneumoperitoneum, before extubation, and one hour after extubation.
Measured: One hour after extubation
Volume of total fluid infusion
The total volume of the administered fluids will be recorded.
Measured: Till the end of surgery
Dosage of vasopressors
The total volume of the administered vasopressors will be recorded.
Measured: Till the end of surgery
Lung ultrasound scores
Lung ultrasound scans will be performed 3 times for each patient, before induction of anesthesia, one hour after extubation and 12 hours postoperatively.
Patients will be scanned in the supine position as follows: Each hemithorax will be divided into 6 regions using 3 longitudinal lines (parasternal, anterior, and posterior axillary) and 2 axial lines (one above the diaphragm and the other 1 cm above the nipples). The 12-lung regions will be scanned sequentially from right to left, cranial to caudal and anterior to posterior. Each region will be assessed using a 2-dimensional view with the probe placed parallel to the ribs. The degree of B-lines will be divided into 4 grades according to lung ultrasound score for consolidation and aeration and scored between 0 and 3:
(0) fewer than 3 isolated B-lines.
- multiple well-defined B-lines.
- multiple coalescent B-lines.
- white lung.
Measured: 12 hours postoperatively
Early postoperative pulmonary complication
Any early postoperative pulmonary complication in the first postoperative 24 hours will be recorded.
Measured: First 24 hours postoperatively
Length of hospital stay
Time from admission till hospital discharge
Measured: 28 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start5 Nov 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive End-expiratory PressureStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Zakaria Mohamed Khattab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115668
- Sponsor's protocol ID
- 36131/11/22
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized Positive End-Expiratory Pressure (PEEP) on Oxygenation, Hemodynamic Variables, and Incidence of Early Postoperative Atelectasis in Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06115668
- Acronym / sponsor ID
- 36131/11/22
- Conditions
- Positive End-expiratory Pressure, Hemodynamic Variable, Postoperative Atelectasis, Laparoscopic Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 3 Nov 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.
The aim of this study is to evaluate the effectiveness of intraoperative individualized positive end-expiratory pressure (PEEPIND) titration, compared to fixed positive end-expiratory pressure of 5 cmH2O, on oxygenation, hemodynamic variables, and early postoperative complications in obese patients undergoing laparoscopic bariatric surgery.
Detailed description
Obesity is a major health problem, and the incidence is increasing worldwide. So far, the only treatment for morbid obesity with good long-term results is bariatric surgery.
Obese patients have unique respiratory physiology and ventilatory mechanics characteristics. Their lung function is impaired due to the reduction of oxygen reserve, functional residual capacity, and lung compliance. In addition, they frequently present with respiratory comorbidities, which increases the risk of developing postoperative pulmonary complications (PPCs) such as atelectasis especially after procedures under general anesthesia. Atelectasis has been hypothesized as a main cause of postoperative hypoxemia.
To reduce the incidence of atelectasis, positive end-expiratory pressure (PEEP) and recruitment maneuvers are used as a protective lung strategy to improve gas exchange and lung mechanics through reopening collapsed alveoli and maintaining the aeration of lungs. Application of PEEP may also eliminate auto-PEEP without increasing plateau pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive end-expiratory pressure 5 (PEEP 5) | Active comparator | Other: Positive end-expiratory pressure 5 (PEEP 5)Patients will receive fixed positive end-expiratory pressure(= 5 cmH2O) as a control group |
| Individualized positive end-expiratory pressure (PEEPIND) | Experimental | Other: Individualized positive end-expiratory pressure (PEEPIND)Patients who will receive the individualized positive end-expiratory pressure. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 21 to 60 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status class I-III
- Patients who are scheduled for elective laparoscopic bariatric surgery under general anesthesia.
Key exclusion criteria (7 listed)
- Patients who are unwilling to participate in the study
- Actively smokers.
- Patients who had a history of Chronic obstructive pulmonary disease or bronchial asthma.
- Patients who are receiving renal replacement therapy prior to surgery.
- Patients who had a history of heart failure.
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 |
|---|---|---|
| Positive end-expiratory pressure 5 (PEEP 5)Fixed positive end-expiratory pressure of 5 cmH2O will be maintained throughout the duration of surgery | Other | Positive end-expiratory pressure 5 (PEEP 5) |
| Individualized positive end-expiratory pressure (PEEPIND)Patients will receive the individualized positive end-expiratory pressure. Titration process will be started after establishment of pneumoperitoneum: setting the initial PEEP to 5 cmH2O, then increasing positive end-expiratory pressure (PEEP)according to the gradient of 2 cmH2O every 3 min, calculating static compliance (Cstat) according to the formula: [Cstat = VT/Pplat - PEEP] (Pplat = plateau pressure), then gradually increasing positive end-expiratory pressure , until the calculated Cstat shows a downward trend, set its previous PEEP (corresponding to PEEP for high Cstat) as the optimal PEEPIND for this patient. The highest PEEP is limited to 20 cmH2O | Other | Individualized positive end-expiratory pressure (PEEPIND) |
Primary outcome
Intraoperative oxygenation
Time frame: One hour after extubation
Intraoperative oxygenation which will be assessed by P/F ratio (the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). PaO2/FiO2: will be measured at before induction of anesthesia, immediately after intubation, after PEEP titration, one hour after pneumoperitoneum, before extubation, one hour after extubation
7 secondary outcomes
Mean arterial pressure(MAP)
Time frame: One hour after extubation
Heart rate(HR)
Time frame: One hour after extubation
Volume of total fluid infusion
Time frame: Till the end of surgery
Dosage of vasopressors
Time frame: Till the end of surgery
Lung ultrasound scores
Time frame: 12 hours postoperatively
Early postoperative pulmonary complication
Time frame: First 24 hours postoperatively
Length of hospital stay
Time frame: 28 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Positive End-expiratory Pressure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Recruiting
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
Postoperative Pulmonary Complications, Mechanical Ventilation
Not yet recruitingPhase 1/2
Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
Congenital Heart Disease, Cardiopulmonary Bypass
RecruitingPhase 1/2
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Congenital Heart Disease, Cardiopulmonary Bypass
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive end-expiratory pressure 5 (PEEP 5) and Individualized positive end-expiratory pressure (PEEPIND) in people with Positive End-expiratory Pressure and Hemodynamic Variable, run by Tanta 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba Z Khattab, Master (00201004774825, hebazakaria194@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative oxygenation (time frame: One hour after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.