Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery

Study Overview
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Brief Summary
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Perioperative pulmonary complications such as atelectasis, hypoxemia, and pneumonia after ventilatory management during general anesthesia have a negative impact on patient outcomes. The possibility of reducing perioperative pulmonary complications by lung recruitment, which uses positive pressure to prevent alveolar collapse, has been reported. Although laparoscopic surgery, which has been widely performed in recent years, can reduce the invasiveness of the operation, it is prone to alveolar collapse due to increased abdominal pressure and diaphragm elevation. The purpose of this study is to verify whether the lung recruitment during laparoscopic surgery in Trendelenburg head-down position prevents hypoxemia due to lung collapse.

Detailed Description
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The multi-center RCT will enroll 80 patients who have laparoscopic surgery in Trendelenburg head-down position. Informed consent will be obtained for study subjects who meet the selection criteria, and the subjects will be enrolled in Electronic Data Capture and randomized into two groups. Patients will be admitted to the operating room for induction of anesthesia and tracheal intubation. In the control group, mechanical ventilation will be performed according to the initial settings and protocols. In the intervention group, after intubation, the ventilator will be initially set up, and the first pulmonary recruitment will be performed immediately after the start of the laparoscopy, followed by recruitment every 30 minutes until the end of the laparoscopy.

Official Title
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Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position

Conditions
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Hypoxia, Perioperative Complication

Intervention / Treatment
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* Procedure: lung recruitment
* Procedure: Standard ventilatory management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing low head laparoscopic surgery who are expected to be laparoscopic for more than 2 hours Exclusion Criteria: Lateral or supine position BMI > 35 One-second rate <70%, %VC <80%, obstructive, restrictive, with bra Cardiovascular disease (NYHA III or higher) Intracranial hypertensive disease Emergency surgery Pregnancy Glaucoma Patients judged unsuitable by the anesthesiologist in charge

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lung recruitment<br>Standard ventilatory management with lung recruitment every 30 minutes | Procedure: lung recruitment<br>* Automatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy.<br>Procedure: Standard ventilatory management<br>* After tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs, if necessary. [initial setting] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight (PBW)<br>|
| Active Comparator: control<br>Standard ventilatory management | Procedure: Standard ventilatory management<br>* After tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs, if necessary. [initial setting] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight (PBW)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoxia | SpO2 less than 95% or more than 2% decrease from baseline | During laparoscopy procedure | 
| Time to onset of hypoxia | Duration from the start of laparoscopic surgery to the onset of hypoxia | During laparoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of decrease in SpO2 | Difference between baseline SpO2 and minimum SpO2 during laparoscopic surgery | During laparoscopy procedure | 
| Ventilator setting at the end of surgery | Ventilator settings such as FIO2, PEEP, and plateau pressure | During surgery | 
| compliance rate of lung recruitment | compliance rate of lung recruitment in the intevention group | During laparoscopy procedure | 
| Safety endpoint: Circulatory agonist use | Circulatory agonist use | During surgery | 
| Safety endpoint: total fluid infusion | total fluid infusion | During surgery | 
| Safety endpoint: incidence of complications | incidence of complications (hypotension, arrhythmia, pneumothorax, atelectasis defined by the blinded investigator) | During surgery | 
| Postoperative hypoxia | Presence of hypoxia the day after surgery | the day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative pulmonary complications, lung recruitment, laparoscopic surgery