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Study of Atelectasis by Electrical Impedance Tomography

Primary Purpose

Gynecologic Surgical Procedures, Urologic Surgical Procedures

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Recruitment maneuver (RM)
Reverse Trend (REV TREND)
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gynecologic Surgical Procedures

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • HUB Hôpital ErasmeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Recruitment maneuver (RM) group 1

Reverse Trend (REV TREND) group 2

Arm Description

Outcomes

Primary Outcome Measures

the percentage of atelectasis after induction of general anesthesia (Time 1)
percentage
the percentage of atelectasis after being positioned in the trendelenburg position (Time 2)
percentage

Secondary Outcome Measures

The eventual possibility of reversal of atelectasis by reverse Trendelenburg position and recruitment maneuver (Time 3)
percentage

Full Information

First Posted
January 26, 2023
Last Updated
March 13, 2023
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05713929
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasme University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Surgical Procedures, Urologic Surgical Procedures

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recruitment maneuver (RM) group 1
Arm Type
Active Comparator
Arm Title
Reverse Trend (REV TREND) group 2
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Recruitment maneuver (RM)
Intervention Description
performance of a recruitment maneuver of 30 cm H20 for 30 seconds and measurement of electrical impedance
Intervention Type
Other
Intervention Name(s)
Reverse Trend (REV TREND)
Intervention Description
Place the patient in the reverse trendelenburg position and measuring the electrical impedance after 5 minutes
Primary Outcome Measure Information:
Title
the percentage of atelectasis after induction of general anesthesia (Time 1)
Description
percentage
Time Frame
from the base measure to time 1 (10 minutes)
Title
the percentage of atelectasis after being positioned in the trendelenburg position (Time 2)
Description
percentage
Time Frame
from the base measure to time 2 (15 minutes)
Secondary Outcome Measure Information:
Title
The eventual possibility of reversal of atelectasis by reverse Trendelenburg position and recruitment maneuver (Time 3)
Description
percentage
Time Frame
from the base measure to time 3 (20 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
HUB Hôpital Erasme
City
Brussels
State/Province
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaut Decoeur, PG
Phone
+32478767308
Email
t.decoeur@hotmail.com
First Name & Middle Initial & Last Name & Degree
Laszlo Szegedi, M.D, PhD
Phone
+3225555546
Email
Laszlo.Szegedi@erasme.ulb.ac.be

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/11172579/
Description
Lung Recruitment
URL
https://pubmed.ncbi.nlm.nih.gov/20608554/
Description
Mechanisms of atelectasis in the perioperative period
URL
https://pubmed.ncbi.nlm.nih.gov/20445445/
Description
Impedance tomography as a new monitoring technique
URL
https://pubmed.ncbi.nlm.nih.gov/21658014/
Description
Effect of Positive End Expiratory Pressure on regional ventilation during laparoscopic surgery monitored by electrical impedance tomography

Learn more about this trial

Study of Atelectasis by Electrical Impedance Tomography

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