Study of Atelectasis by Electrical Impedance Tomography

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urologic Surgical Procedures; Gynecologic Surgical Procedures
• Intervention / Treatment: Other: Recruitment maneuver (RM); Other: Reverse Trend (REV TREND)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Anderlecht
    • Brussels, Anderlecht, Belgium, 1070
      • Recruiting
      • HUB Hôpital Erasme
      • Contact: Thibaut Decoeur, PG; Phone Number: +32478767308; Email: t.decoeur@hotmail.com
      • Contact: Laszlo Szegedi, M.D, PhD; Phone Number: +3225555546; Email: Laszlo.Szegedi@erasme.ulb.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: B4062022000256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No