Study of Atelectasis by Electrical Impedance Tomography

Sponsor

Erasme University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05713929

Collaborator

(none)

Enrollment

Location

Arms

6.9

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Surgical Procedures Urologic Surgical Procedures	Other: Recruitment maneuver (RM) Other: Reverse Trend (REV TREND)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1st measurement (T0-SPONT): in spontaneous ventilation. Induction, intubation and mechanical ventilation for 5 minutes. 2nd measurement (T1-LYING): after induction. Trendelenburg 30° and ventilatory constant parameters. 3rd measurement (T2-TREND): after 5 minutes of Trendelenburg. Division into 2 groups according to randomization: I. Supine position and recruitment manoeuvre. 4th measurement after 5 minutes. (T3-RM) II. Either put in the Anti Trendelenburg position. 4th measurement after 5 minutes. (TREND Q3- REV) Horizontal supine position and surgical incision.1st measurement (T0-SPONT): in spontaneous ventilation. Induction, intubation and mechanical ventilation for 5 minutes. 2nd measurement (T1-LYING): after induction. Trendelenburg 30° and ventilatory constant parameters. 3rd measurement (T2-TREND): after 5 minutes of Trendelenburg.Division into 2 groups according to randomization:Supine position and recruitment manoeuvre. 4th measurement after 5 minutes. (T3-RM) II. Either put in the Anti Trendelenburg position. 4th measurement after 5 minutes. (TREND Q3- REV) Horizontal supine position and surgical incision.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Recruitment maneuver (RM) group 1	Other: Recruitment maneuver (RM) performance of a recruitment maneuver of 30 cm H20 for 30 seconds and measurement of electrical impedance
Active Comparator: Reverse Trend (REV TREND) group 2	Other: Reverse Trend (REV TREND) Place the patient in the reverse trendelenburg position and measuring the electrical impedance after 5 minutes

Arm

Intervention/Treatment

Active Comparator: Recruitment maneuver (RM) group 1

Other: Recruitment maneuver (RM)

performance of a recruitment maneuver of 30 cm H20 for 30 seconds and measurement of electrical impedance

Active Comparator: Reverse Trend (REV TREND) group 2

Other: Reverse Trend (REV TREND)

Place the patient in the reverse trendelenburg position and measuring the electrical impedance after 5 minutes

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HUB Hôpital Erasme	Brussels	Anderlecht	Belgium	1070

Sponsors and Collaborators

Erasme University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Erasme University Hospital

ClinicalTrials.gov Identifier:

NCT05713929

Other Study ID Numbers:

B4062022000256

First Posted:

Feb 6, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Atelectasis

Study Results

No Results Posted as of Feb 8, 2023