High Versus Low Positive End Expiratory Pressure With Alveolar Recruitment Maneuver in Laparoscopic Bariatric Surgeries

April 5, 2019 updated by: Mahmoud Othman, Mansoura University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

A) 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.

B) Intraoperative hypotension (systolic blood pressure <90 mmHg):

  1. Abort any recruitment maneuver in low PEEP+ RM group.
  2. Gradual decrease PEEP by 5 cmH2O in stepwise manner in higher PEEP group.
  3. Give 500 ml bolus colloid and correct fluid status with blood transfusion if indicated.
  4. Noradrenalin infusion as last resort

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansourah, Dakahlia, Egypt
        • Mansoura Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) physical status II and III.
  2. Patients included in the study having body mass index ≥35kg/m2.
  3. Both genders.
  4. Age ≥ 20 years old.

Exclusion Criteria:

  1. Major cardiovascular diseases (heart failure and ejection fraction below 40%).
  2. Sever obstructive pulmonary diseases (FEV1 < 50 and FVC < 50)
  3. Hepatic and renal impairment.
  4. Younger than 20 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Recruitment with low PEEP
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 .
Device: Recruitment with low PEEP
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 .
Other Names:
  • Low PEEP + RM
Active Comparator: High PEEP without RM

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).
Device: High PEEP without RM
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.
Other Names:
  • High PEEP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During intra-operative mechanical ventilation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Horowitz ratio
Time Frame: During mechanical ventilation
Improvement of intraoperative oxygenation with Horowitz ratio (Pao2/Fio2) more than 350.
During mechanical ventilation
Alveolar dead space ratio
Time Frame: During mechanical ventilation
Achievement of the least alveolar dead space ratio (vd/vt).
During mechanical ventilation
Systolic blood pressure
Time Frame: During mechanical ventilation
Maintain systolic blood pressure above 100 mmHg.
During mechanical ventilation
Diastolic blood pressure
Time Frame: During mechanical ventilation
Maintain diastolic blood pressure above 50 mmHg.
During mechanical ventilation
Mean blood pressure
Time Frame: During mechanical ventilation
Maintain mean blood pressure above 65 mmHg.
During mechanical ventilation
Heart rate
Time Frame: During mechanical ventilation
Maintain heart rate within the range of 60-90 (bpm ).
During mechanical ventilation
Analgesia
Time Frame: postoperative time for 24 hours
postoperative visual analogue score less than 4.
postoperative time for 24 hours
Atelectasis
Time Frame: postoperative time for 24 hours
Chest X-ray for evidences of atelectasis
postoperative time for 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Amgad A Zaghloul, MD, Mansoura University
  • Study Chair: Ahmed M Farid, MD, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MD/16.3.24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No available other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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