Study of Atelectasis by Electrical Impedance Tomography

Not Applicable

Recruiting

• Conditions: Gynecologic Surgical Procedures; Urologic Surgical Procedures
• Interventions: Other: Recruitment maneuver (RM); Other: Reverse Trend (REV TREND)

• Registration Number: NCT05713929
• Lead Sponsor: Erasme University Hospital

Brief Summary

The goal of this interventional study is to learn about the effects of different positions on the occurrence, regional distribution and reversibility of atelectasis by using a PulmoVista 500 monitor (Dräger. 23542 Lübeck), during general anesthesia with mechanical ventilation.

The main questions it aims to answer are:

* The increase in atelectasis after induction of general anesthesia in supine and Trendelenburg position compared with baseline (spontaneous breathing)

* The eventual possibility of reversal of atelectasis caused by general anesthesia and Trendelenburg position by reverse Trendelenburg position and recruitment manœuvre.

Participants will be adult, autonomous and able to express their will, undergoing elective gynecological or urological surgery in the extended Trendelenburg position.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-01-26
• Study Start: 2023-02-06
• Study First Posted: 2023-02-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult subjects over eighteen years old;
• Requiring laparoscopic gynecological, urological or digestive surgery;
• Surgery requiring Trendelenburg position and tracheal intubation.

Exclusion Criteria

• Emergency operation;
• Thoracic surgery;
• Pulmonary, cardiac pathology;
• Pregnant woman;
• BMI > 30;
• Comorbidities defined as an American Society of Anesthesiologists physical condition greater than 2;
• Language barrier;
• Refusal of consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recruitment maneuver (RM) group 1	Recruitment maneuver (RM)	-
Reverse Trend (REV TREND) group 2	Reverse Trend (REV TREND)	-

Primary Outcome Measures

Name	Time	Method
the percentage of atelectasis after induction of general anesthesia (Time 1)	from the base measure to time 1 (10 minutes)	percentage
the percentage of atelectasis after being positioned in the trendelenburg position (Time 2)	from the base measure to time 2 (15 minutes)	percentage

Secondary Outcome Measures

Name	Time	Method
The eventual possibility of reversal of atelectasis by reverse Trendelenburg position and recruitment maneuver (Time 3)	from the base measure to time 3 (20 minutes)	percentage

Trial Locations

Locations (1)

HUB Hôpital Erasme; 🇧🇪 Brussels, Anderlecht, Belgium