Study of Atelectasis by Electrical Impedance Tomography

Gynecologic Surgical Procedures Clinical Trial

Official title:

Study of Atelectasis by Electrical Impedance Tomography and the Effects of Different Positions on Their Occurrence, Reversibility and Regional Distribution, During General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713929
• Other study ID #: B4062022000256
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2023
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gynecologic Surgical Procedures
• Pulmonary Atelectasis
• Urologic Surgical Procedures

Intervention

Other:
• Recruitment maneuver (RM)
performance of a recruitment maneuver of 30 cm H20 for 30 seconds and measurement of electrical impedance
• Reverse Trend (REV TREND)
Place the patient in the reverse trendelenburg position and measuring the electrical impedance after 5 minutes

Locations

Country	Name	City	State
Belgium	HUB Hôpital Erasme	Brussels	Anderlecht

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of atelectasis after induction of general anesthesia (Time 1)	percentage	from the base measure to time 1 (10 minutes)
Primary	the percentage of atelectasis after being positioned in the trendelenburg position (Time 2)	percentage	from the base measure to time 2 (15 minutes)
Secondary	The eventual possibility of reversal of atelectasis by reverse Trendelenburg position and recruitment maneuver (Time 3)	percentage	from the base measure to time 3 (20 minutes)

External Links

•   Effect of Positive End Expiratory Pressure on regional ventilation during laparoscopic surgery monitored by electrical impedance tomography
•   Impedance tomography as a new monitoring technique
•   Lung Recruitment
•   Mechanisms of atelectasis in the perioperative period