Study of Atelectasis by Electrical Impedance Tomography

NCT ID: NCT05713929

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2023-08-31

Brief Summary

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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

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Conditions

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Gynecologic Surgical Procedures Urologic Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Recruitment maneuver (RM) group 1

Group Type ACTIVE_COMPARATOR

Recruitment maneuver (RM)

Intervention Type OTHER

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

Reverse Trend (REV TREND) group 2

Group Type ACTIVE_COMPARATOR

Reverse Trend (REV TREND)

Intervention Type OTHER

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

Interventions

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Recruitment maneuver (RM)

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

Intervention Type OTHER

Reverse Trend (REV TREND)

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HUB Hôpital Erasme

Brussels, Anderlecht, Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Thibaut Decoeur, PG

Role: primary

+32478767308

Laszlo Szegedi, M.D, PhD

Role: backup

+3225555546

Related Links

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https://pubmed.ncbi.nlm.nih.gov/20608554/

Mechanisms of atelectasis in the perioperative period

https://pubmed.ncbi.nlm.nih.gov/20445445/

Impedance tomography as a new monitoring technique

https://pubmed.ncbi.nlm.nih.gov/21658014/

Effect of Positive End Expiratory Pressure on regional ventilation during laparoscopic surgery monitored by electrical impedance tomography

Other Identifiers

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B4062022000256

Identifier Type: -

Identifier Source: org_study_id

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