AnesthesiaNCT03505632
High Versus Low Positive End Expiratory Pressure With Alveolar Recruitment Maneuver in Laparoscopic Bariatric Surgeries
A study testing Recruitment with low PEEP and High PEEP without RM in people with Anesthesia, run by Mansoura University at 1 site in Egypt.
Trial summary
For the patients undergoing laparoscopic bariatric surgery, application of low (PEEP) with frequent alveolar recruitment maneuver could be beneficial and superior to conventional ventilation with a high (PEEP) in improving lung compliance, better oxygenation and less dead space .This hypothesis could be achieved by… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Recruitment with low PEEP and High PEEP without RM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 31 Mar 2019
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status II and III.
- Patients included in the study having body mass index ≥35kg/m2.
- Both genders.
- Age ≥ 20 years old.
Who cannot join
- Major cardiovascular diseases (heart failure and ejection fraction below 40%).
- Sever obstructive pulmonary diseases (FEV1 < 50 and FVC < 50)
- Hepatic and renal impairment.
- Younger than 20 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Positive End Expiratory Pressure With Alveolar Recruitment Maneveurs Versus High Positive End Expiratory Pressure as Lung Protective Strategy in Laparoscopic Bariatric Surgeries
For the patients undergoing laparoscopic bariatric surgery, application of low (PEEP) with frequent alveolar recruitment maneuver could be beneficial and superior to conventional ventilation with a high (PEEP) in improving lung compliance, better oxygenation and less dead space .This hypothesis could be achieved by minimizing the expected lung atelectasis during anesthesia for this particular kind of laparoscopic surgery without any haemodynamics alterations.This trial was designed to study the effects of alveolar recruitment strategy with low PEEP versus conventional mechanical ventilation with higher PEEP on the patients undergoing laparoscopic bariatric surgeries. The primary end point of the study will be the achievement of the highest dynamic lung compliance (Cdyn). Improvement of intraoperative oxygenation (Pao2/Fio2) and achievement of a lower dead space ratio (vd/vt), with stable intraoperative haemodynamics will be considered as secondary outcome
Read the detailed description
The use of a alveolar recruitment maneuver(RM) effectively increases end expiratory lung volume and reopens lung atelectasis during anesthesia and reproduces better oxygenation for surgical obese patients .Alveolar recruitment maneuver with PEEP could decreases atelectasis and improved oxygenation in obese surgical patients .This concept indicate that the maintenance of low PEEP after multiple alveolar recruitment maneuver during anesthesia may improve its benefits without complications. Patients will randomly divided by computerized randomization sequence method into two groups (30 patients in each study group):
Both groups receive volume controlled ventilation, tidal volume was 6-8 ml/kg for predicted body weight. The PBW calculated according to a formula: 50 + 0.91 × {height (cm)-152.4} for men and 45.5 + 0.91 × {height (cm) - 152.4} for women. The respiratory rate was adjusted to keep the EtCO2= 35-40 mmHg. The inspiratory to expiratory ratio (I:E ratio) was 1:2 and the FiO2 was 0.40.
Low PEEP+RM group: Patients receive PEEP of 5cmH2O. Recruitment maneuver ( RM) will be done by increasing the PEEP in stepwise manner. First PEEP was increased to 10 cmH2O (3 breaths),then to 15 cm H2O (3 breaths).Finally, PEEP was raised to 20 cmH2O (10 breaths).Then decreased for 15cmH2O for (3 breaths),10cmH2O for(3 breaths), and finally returned back to original PEEP 5 cmH2O.The total procedure took 2 min. Recruitment will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40cmH2O.
High PEEP group: Patients receive throughout ventilation 15 cm H2O PEEP with maintaining the peak airway pressure below 40 cm H2O.
Monitoring :after intubation(T1), post-insufflation(T2), after disinflation (T3) and before extubation(T4) for the fillowoing.1--Minute volume ,respiratory rate and tidal volume 2-Arterial blood gas( PaO2, PaCO2,pH).3-Hemodynamics : heart rate and invasive arterial blood pressure.4-Calculated dynamic Lung compliance by equation: T V/peak airway pressure- PEEP .5-calculated driving pressure by equation: Pplat-PEEP.6-Calculated dead space ratio (VD/VT) by equation :PaCO2-ETCO2)/ PaCO2.
Rescue strategies:
- Intraoperative hypoxemia (SpO2≤92%): In both groups ,rescue primarily will be performed by an increase in FiO2 by 0.1 till reaching oxygen (100% ) .If failed and hypoxia persist a recruitment maneuver will be carried out with stepwise incremental PEEP irrespective of the group allocation.
The time of the event of hypoxia and its management will be recorded.
- Intraoperative hypotension (systolic blood pressure <90 mmHg):
- Abort any recruitment maneuver in low PEEP+ RM group.
- Gradual decrease PEEP by 5 cmH2O in stepwise manner in higher PEEP group.
- Give 500 ml bolus colloid and correct fluid status with blood transfusion if indicated.
- Noradrenalin infusion as last resort
- Conditions
- Anesthesia
- Being tested
- Recruitment with low PEEP, High PEEP without RM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment with low PEEPDevice
Also called Low PEEP + RM
Volume controlled ventilation with TV 6-8 ml/PBW . RR adjusted to keep the EtCO2 35-40 mmHg. I/E ratio1:2 and FiO2 0.40.Patients will receive PEEP of 5cmH2O. RM will be done by increasing the PEEP in stepwise manner. First PEEP increase to 10 cmH2O (3 breaths),then to 15 cm H2O (3 breaths) and finally PEEP raise to 20 cmH2O (10 breaths).Then PEEP decrease by 5 cmH2O increments every (3 breaths) until back to PEEP 5 cmH2O. RM will take 2 minutes. RM will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40 cmH2O. Monitoring of the following parameters :Dynamic lung compliance ,Horowitz index ,dead space and driving pressure .
High PEEP without RMDevice
Also called High PEEP
Volume controlled ventilation will carried out with tidal volume 6-8 ml/kg for predicted body weight. The PBW calculated according to the formula : 50 + 0.91 × {height (cm)-152.4} for men and 45.5 + 0.91 × {height (cm) - 152.4} for women. The respiratory rate adjusted to keep the EtCO2= 35-40 mmHg. The inspiratory to expiratory ratio (I:E ratio) 1:2 and FiO2 0.40.Patients will receive high PEEP of 15cmH2O from the start and continue all through the procedure . Monitoring of dynamic lung compliance,Horowitz index,dead space and driving pressure will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Recruitment with low PEEP | Experimental | Recruitment maneuver ( RM) will carried out during 2 minutes with increasing PEEP in stepwise manner.PEEP increase from 5 to 10 cmH2O (3 breaths),then to 15 cm H2O (3 breaths), PEEP to 20 cmH2O (10 breaths).Then decrease by 5 cmH2O every 3 breaths till back to preset PEEP 5 cmH2O .Recruitment carried out at the following times: post intubation(T1) , after insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40cmH2O . Receives: Device: Recruitment with low PEEP |
| High PEEP without RM | Active comparator | Patients will receive from the start during anesthesia high PEEP (15 cmH2O) with maintaining the peak airway pressure below 40 cm H2O.
Monitoring times: after intubation(T1), post-insufflation(T2), after desuflation (T3) and before extubation(T4). Receives: Device: High PEEP without RM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic lung compliance
To achieve nearly 20% increase in dynamic lung compliance (Cdyn) during anesthesia for obese patients undergoing bariatric surgery.
Measured: During intra-operative mechanical ventilation
Secondary outcomes (8)
Horowitz ratio
Improvement of intraoperative oxygenation with Horowitz ratio (Pao2/Fio2) more than 350.
Measured: During mechanical ventilation
Alveolar dead space ratio
Achievement of the least alveolar dead space ratio (vd/vt).
Measured: During mechanical ventilation
Systolic blood pressure
Maintain systolic blood pressure above 100 mmHg.
Measured: During mechanical ventilation
Diastolic blood pressure
Maintain diastolic blood pressure above 50 mmHg.
Measured: During mechanical ventilation
Mean blood pressure
Maintain mean blood pressure above 65 mmHg.
Measured: During mechanical ventilation
Heart rate
Maintain heart rate within the range of 60-90 (bpm ).
Measured: During mechanical ventilation
Analgesia
postoperative visual analogue score less than 4.
Measured: postoperative time for 24 hours
Atelectasis
Chest X-ray for evidences of atelectasis
Measured: postoperative time for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 Jun 2017
- Primary completion1 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mechanical ventilation with either recruitment maneuver and low PEEP versus conventional mechanical ventilation and high PEEP
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Othman, Mansoura University
- Investigators
- Amgad A Zaghloul, MD, Study chair, Mansoura UniversityAhmed M Farid, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505632
- Sponsor's protocol ID
- MD/16.3.24
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2018
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No available other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Positive End Expiratory Pressure With Alveolar Recruitment Maneveurs Versus High Positive End Expiratory Pressure as Lung Protective Strategy in Laparoscopic Bariatric Surgeries
- ClinicalTrials.gov ID
- NCT03505632
- Acronym / sponsor ID
- MD/16.3.24
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 23 Apr 2018 (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.
For the patients undergoing laparoscopic bariatric surgery, application of low (PEEP) with frequent alveolar recruitment maneuver could be beneficial and superior to conventional ventilation with a high (PEEP) in improving lung compliance, better oxygenation and less dead space .This hypothesis could be achieved by minimizing the expected lung atelectasis during anesthesia for this particular kind of laparoscopic surgery without any haemodynamics alterations.This trial was designed to study the effects of alveolar recruitment strategy with low PEEP versus conventional mechanical ventilation with higher PEEP on the patients undergoing laparoscopic bariatric surgeries. The primary end point of the study will be the achievement of the highest dynamic lung compliance (Cdyn). Improvement of intraoperative oxygenation (Pao2/Fio2) and achievement of a lower dead space ratio (vd/vt), with stable intraoperative haemodynamics will be considered as secondary outcome
Detailed description
The use of a alveolar recruitment maneuver(RM) effectively increases end expiratory lung volume and reopens lung atelectasis during anesthesia and reproduces better oxygenation for surgical obese patients .Alveolar recruitment maneuver with PEEP could decreases atelectasis and improved oxygenation in obese surgical patients .This concept indicate that the maintenance of low PEEP after multiple alveolar recruitment maneuver during anesthesia may improve its benefits without complications. Patients will randomly divided by computerized randomization sequence method into two groups (30 patients in each study group):
Both groups receive volume controlled ventilation, tidal volume was 6-8 ml/kg for predicted body weight. The PBW calculated according to a formula: 50 + 0.91 × {height (cm)-152.4} for men and 45.5 + 0.91 × {height (cm) - 152.4} for women. The respiratory rate was adjusted to keep the EtCO2= 35-40 mmHg. The inspiratory to expiratory ratio (I:E ratio) was 1:2 and the FiO2 was 0.40.
Low PEEP+RM group: Patients receive PEEP of 5cmH2O. Recruitment maneuver ( RM) will be done by increasing the PEEP in stepwise manner. First PEEP was increased to 10 cmH2O (3 breaths),then to 15 cm H2O (3 breaths).Finally, PEEP was raised to 20 cmH2O (10 breaths).Then decreased for 15cmH2O for (3 breaths),10cmH2O for(3 breaths), and finally returned back to original PEEP 5 cmH2O.The total procedure took 2 min. Recruitment will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40cmH2O.
High PEEP group: Patients receive throughout ventilation 15 cm H2O PEEP with maintaining the peak airway pressure below 40 cm H2O.
Monitoring :after intubation(T1), post-insufflation(T2), after disinflation (T3) and before extubation(T4) for the fillowoing.1--Minute volume ,respiratory rate and tidal volume 2-Arterial blood gas( PaO2, PaCO2,pH).3-Hemodynamics : heart rate and invasive arterial blood pressure.4-Calculated dynamic Lung compliance by equation: T V/peak airway pressure- PEEP .5-calculated driving pressure by equation: Pplat-PEEP.6-Calculated dead space ratio (VD/VT) by equation :PaCO2-ETCO2)/ PaCO2.
Rescue strategies:
- Intraoperative hypoxemia (SpO2≤92%): In both groups ,rescue primarily will be performed by an increase in FiO2 by 0.1 till reaching oxygen (100% ) .If failed and hypoxia persist a recruitment maneuver will be carried out with stepwise incremental PEEP irrespective of the group allocation.
The time of the event of hypoxia and its management will be recorded.
- Intraoperative hypotension (systolic blood pressure <90 mmHg):
- Abort any recruitment maneuver in low PEEP+ RM group.
- Gradual decrease PEEP by 5 cmH2O in stepwise manner in higher PEEP group.
- Give 500 ml bolus colloid and correct fluid status with blood transfusion if indicated.
- Noradrenalin infusion as last resort
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Mechanical ventilation with either recruitment maneuver and low PEEP versus conventional mechanical ventilation and high PEEP
| Arm | Type | Receives |
|---|---|---|
| Recruitment with low PEEP | Experimental | Device: Recruitment with low PEEPRecruitment maneuver ( RM) will carried out during 2 minutes with increasing PEEP in stepwise manner.PEEP increase from 5 to 10 cmH2O (3 breaths),then to 15 cm H2O (3 breaths), PEEP to 20 cmH2O (10 breaths).Then decrease by 5 cmH2O every 3 breaths till back to preset PEEP 5 cmH2O .Recruitment carried out at the following times: post intubation(T1) , after insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40cmH2O . |
| High PEEP without RM | Active comparator | Device: High PEEP without RMPatients will receive from the start during anesthesia high PEEP (15 cmH2O) with maintaining the peak airway pressure below 40 cm H2O. Monitoring times: after intubation(T1), post-insufflation(T2), after desuflation (T3) and before extubation(T4). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status II and III.
- Patients included in the study having body mass index ≥35kg/m2.
- Both genders.
- Age ≥ 20 years old.
Key exclusion criteria (4 listed)
- Major cardiovascular diseases (heart failure and ejection fraction below 40%).
- Sever obstructive pulmonary diseases (FEV1 < 50 and FVC < 50)
- Hepatic and renal impairment.
- Younger than 20 years old.
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 |
|---|---|---|
| Recruitment with low PEEPAlso: Low PEEP + RMVolume controlled ventilation with TV 6-8 ml/PBW . RR adjusted to keep the EtCO2 35-40 mmHg. I/E ratio1:2 and FiO2 0.40.Patients will receive PEEP of 5cmH2O. RM will be done by increasing the PEEP in stepwise manner. First PEEP increase to 10 cmH2O (3 breaths),then to 15 cm H2O (3 breaths) and finally PEEP raise to 20 cmH2O (10 breaths).Then PEEP decrease by 5 cmH2O increments every (3 breaths) until back to PEEP 5 cmH2O. RM will take 2 minutes. RM will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40 cmH2O. Monitoring of the following parameters :Dynamic lung compliance ,Horowitz index ,dead space and driving pressure . | Device | Recruitment with low PEEP |
| High PEEP without RMAlso: High PEEPVolume controlled ventilation will carried out with tidal volume 6-8 ml/kg for predicted body weight. The PBW calculated according to the formula : 50 + 0.91 × {height (cm)-152.4} for men and 45.5 + 0.91 × {height (cm) - 152.4} for women. The respiratory rate adjusted to keep the EtCO2= 35-40 mmHg. The inspiratory to expiratory ratio (I:E ratio) 1:2 and FiO2 0.40.Patients will receive high PEEP of 15cmH2O from the start and continue all through the procedure . Monitoring of dynamic lung compliance,Horowitz index,dead space and driving pressure will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40cmH2O. | Device | High PEEP without RM |
Primary outcome
Dynamic lung compliance
Time frame: During intra-operative mechanical ventilation
To achieve nearly 20% increase in dynamic lung compliance (Cdyn) during anesthesia for obese patients undergoing bariatric surgery.
8 secondary outcomes
Horowitz ratio
Time frame: During mechanical ventilation
Alveolar dead space ratio
Time frame: During mechanical ventilation
Systolic blood pressure
Time frame: During mechanical ventilation
Diastolic blood pressure
Time frame: During mechanical ventilation
Mean blood pressure
Time frame: During mechanical ventilation
Heart rate
Time frame: During mechanical ventilation
Analgesia
Time frame: postoperative time for 24 hours
Atelectasis
Time frame: postoperative time for 24 hours
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 8 Apr 2019.
- Individual participant dataSharing planned: No. No available other researchers
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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.
Amgad A Zaghloul, MD study chair
Mansoura University
Ahmed M Farid, MD study chair
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 Recruitment with low PEEP and High PEEP without RM in people with Anesthesia, 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 4 inclusion and 4 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 8 Apr 2019. 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?
Dynamic lung compliance (time frame: During intra-operative mechanical ventilation). 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 8 Apr 2019.