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Study of Atelectasis by Electrical Impedance Tomography

F

Free University of Brussels (ULB)

Status

Enrolling

Conditions

Urologic Surgical Procedures
Gynecologic Surgical Procedures

Treatments

Other: Reverse Trend (REV TREND)
Other: Recruitment maneuver (RM)

Study type

Interventional

Funder types

Other

Identifiers

NCT05713929
B4062022000256

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Recruitment maneuver (RM) group 1
Active Comparator group
Treatment:
Other: Recruitment maneuver (RM)
Reverse Trend (REV TREND) group 2
Active Comparator group
Treatment:
Other: Reverse Trend (REV TREND)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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