Study of Atelectasis by Electrical Impedance Tomography

NCT05713929 | Unknown

• 1 other identifier: B4062022000256
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Surgical Procedures; Urologic Surgical Procedures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Recruitment maneuver (RM) group 1

ACTIVE COMPARATOR

Other: Recruitment maneuver (RM)

Reverse Trend (REV TREND) group 2

ACTIVE COMPARATOR

Other: Reverse Trend (REV TREND)

Interventions

Recruitment maneuver (RM) OTHER

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

Recruitment maneuver (RM) group 1

Reverse Trend (REV TREND) OTHER

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

Reverse Trend (REV TREND) group 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

HUB Hôpital Erasme

Brussels, Anderlecht, 1070, Belgium

RECRUITING

Related 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. 1st measurement (T0-SPONT): in spontaneous ventilation. 2. Induction, intubation and mechanical ventilation for 5 minutes. 3. 2nd measurement (T1-LYING): after induction. 4. Trendelenburg 30° and ventilatory constant parameters. 5. 3rd measurement (T2-TREND): after 5 minutes of Trendelenburg. 6. 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) 7. Horizontal supine position and surgical incision.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: February 6, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)