Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics of Obese Laparoscopic Abdominal Surgery Patients

Not Applicable

• Conditions: Recruitment; Obesity, Morbid; Laparoscopy
• Interventions: Procedure: No recruitment maneuver; Procedure: Recruitment maneuver

• Registration Number: NCT04269226
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

This study aims to demonstrate the effects of automatic recruitment maneuver on peroperative lung mechanics of obese patients undergoing laparoscopic abdominal surgery.

128 obese patients undergoing abdominal laparoscopic surgery are randomly going to be assigned to automatic recruitment maneuver group and no recruitment maneuver group (control group). Both groups are going to be taken to the operating table. Electrocardiography (ECG), noninvasive blood pressure (NIBP), pulse oximeter and peripheral oxygen saturation (SpO2) and post-intubation end-tidal carbon dioxide (EtCO2) and train of four (TOF) monitoring will be performed. Then, general anesthesia induction procedure will be started. Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal PEEP (Positive end-expiratory pressure) for the patient, and PEEP (Positive end-expiratory pressure) will be adjusted at this value after recruitment. If MAP (mean arterial pressure) is \<60 mmHg during the maneuver, the maneuver will be terminated and these patients will be excluded from the study. Respiratory mechanics for both groups (peak pressure, plateau pressure, driver pressure, static compliance, dynamic compliance, EtCO2) and hemodynamic parameters (heart peak, mean arterial pressure, SpO2) at 5 different times (T1: post intubation; T2 : after insufflation; T3: 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver) will be recorded. Throughout the surgery, insufflation pressure will be kept as 10-13 cmH20. At the end of the surgery, the anesthesia maintenance of all patients will be terminated and the routine wake-up phase will be initiated. Creatinine values and hourly urine outputs of all patients routinely monitored at the postoperative 24th hour will be recorded on the case follow-up form.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-09
• Status Verified: 2020-02
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-12
• Last Update Submitted: 2020-02-12
• Study First Posted: 2020-02-13
• Last Update Posted: 2020-02-13
• Primary Completion: 2020-04-09
• Study Completion: 2020-05-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. Patients between the ages of 18 and 65
2. Body mass index (BMI)> 30 patients undergoing laparoscopic abdominal surgery
3. ASA (American Society of Anesthesiologists) 2-3 patients

Exclusion Criteria

1. Smokers
2. Patients with previous abdominal surgery
3. Patients with obstructive / restrictive lung disease,
4. Patients with coronary artery disease, heart failure
5. Patients with chronic kidney failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No recruitment maneuver	No recruitment maneuver	No recruitment maneuver
Recruitment maneuver	Recruitment maneuver	Recruitment maneuver

Primary Outcome Measures

Name	Time	Method
Peak airway pressure	1 week	This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Plateau airway pressure	1 week	This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Driver airway pressure	1 week	This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Static airway compliance	1 week	This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Dynamic airway compliance	1 week	This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
End tidal CO2 pressure	1 week	This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)

Secondary Outcome Measures

Name	Time	Method
Heart rate	1 week	This will me measured at 5 different times using electrocardiography and will be reported as beat per minute (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Mean arterial pressure	1 week	This will me measured at 5 different times using non invasive blood pressure monitor and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
SpO2	1 week	SpO2 will me measured at 5 different times using pulse oximetry and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Creatinine	24th hour	Creatinine values will be measured at 24th our using blood tests and will be reported as mg/dL
Urine output	24th hour	This will be measured hourly for the first 24 hours, using urinary catheter and will be reported as ml per hour.

Trial Locations

Locations (1)

Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Turkey