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

NCT03505632 | Completed DMC

• 1 other identifier: MD/16.3.24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Dynamic lung compliance

  To achieve nearly 20% increase in dynamic lung compliance (Cdyn) during anesthesia for obese patients undergoing bariatric surgery.

  During intra-operative mechanical ventilation

Secondary Outcomes (8)

• Horowitz ratio

  During mechanical ventilation

• Alveolar dead space ratio

  During mechanical ventilation

• Systolic blood pressure

  During mechanical ventilation

• Diastolic blood pressure

  During mechanical ventilation

• Mean blood pressure

  During mechanical ventilation

Study Arms (2)

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 .

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).

Device: High PEEP without RM

Interventions

Recruitment with low PEEP DEVICE

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 .

Also known as: Low PEEP + RM

Recruitment with low PEEP

High PEEP without RM DEVICE

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.

Also known as: High PEEP

High PEEP without RM

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura faculty of medicine

Al Mansurah, Dakahlia Governorate, Egypt

Location

Study Officials

• Amgad A Zaghloul, MD

  Mansoura University

  STUDY CHAIR

• Ahmed M Farid, MD

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study is double blind study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Anesthesia and surgical ICU

Model Details: Mechanical ventilation with either recruitment maneuver and low PEEP versus conventional mechanical ventilation and high PEEP

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 23, 2018
• Study Start: June 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 31, 2019
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)