Clinical trial NCT05713929: Study of Atelectasis by Electrical Impedance Tomography
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Surgical Procedures
Urologic Surgical Procedures
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: the percentage of atelectasis after induction of general anesthesia (Time 1)
timeFrame: from the base measure to time 1 (10 minutes)
measure: the percentage of atelectasis after being positioned in the trendelenburg position (Time 2)
timeFrame: from the base measure to time 2 (15 minutes)
Secondary outcomes:
measure: The eventual possibility of reversal of atelectasis by reverse Trendelenburg position and recruitment maneuver (Time 3)
timeFrame: from the base measure to time 3 (20 minutes)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: HUB Hôpital Erasme
state: Anderlecht
Study officials:
References: