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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: High PEEP without RM; Device: Recruitment with low PEEP

• Registration Number: NCT03505632
• Lead Sponsor: Mansoura University

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-23
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High PEEP without RM	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).
Recruitment with low PEEP	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 .

Primary Outcome Measures

Name	Time	Method
Dynamic lung compliance	During intra-operative mechanical ventilation	To achieve nearly 20% increase in dynamic lung compliance (Cdyn) during anesthesia for obese patients undergoing bariatric surgery.

Secondary Outcome Measures

Name	Time	Method
Alveolar dead space ratio	During mechanical ventilation	Achievement of the least alveolar dead space ratio (vd/vt).
Heart rate	During mechanical ventilation	Maintain heart rate within the range of 60-90 (bpm ).
Atelectasis	postoperative time for 24 hours	Chest X-ray for evidences of atelectasis
Systolic blood pressure	During mechanical ventilation	Maintain systolic blood pressure above 100 mmHg.
Diastolic blood pressure	During mechanical ventilation	Maintain diastolic blood pressure above 50 mmHg.
Mean blood pressure	During mechanical ventilation	Maintain mean blood pressure above 65 mmHg.
Horowitz ratio	During mechanical ventilation	Improvement of intraoperative oxygenation with Horowitz ratio (Pao2/Fio2) more than 350.
Analgesia	postoperative time for 24 hours	postoperative visual analogue score less than 4.

Trial Locations

Locations (1)

Mansoura faculty of medicine; 🇪🇬 Mansourah, Dakahlia, Egypt