Bariatric Electrical Impedance Tomography

NCT05187039 | Completed

• 1 other identifier: 2021-01473
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates under controlled conditions the variation of poorly ventilated lung units (silent spaces) in obese patients scheduled for laparoscopic bariatric surgery in the perioperative phase.

Conditions

Anesthesia

Keywords

Bariatric; Obese; Laparoscopic; Electrical impedance tomography

Outcome Measures

Primary Outcomes (1)

• Proportion of poorly ventilated lung areas (silent spaces)

  Proportion of poorly ventilated lung areas (silent spaces) by using electrical impedance tomography (EIT) before the discharge from PACU (two hours after admission to PACU).

  2 hours

Secondary Outcomes (9)

• EIT-Measurement after the end of induction before the surgical procedure

  2 minutes after the end of anesthesia induction

• EIT-Measurement at the end of the surgical procedure

  5 minutes after Capnoperitoneum

• EIT-Measurement 2 minutes after the end of anaesthesia, before the transport in PACU

  2 minutes after the end of anaesthesia, before the transport to PACU.

• EIT-Measurement before discharge from the PACU

  Two hours after admission of the patient at PACU, before first mobilisation and before discharge from PACU

• EIT-Measurement before discharging the patient at home

  At hospital discharge, up to 3 days

Interventions

Electrical impedance tomography during anesthesia OTHER

Thoracic electrical impedance tomography measurements ( min each) will be performed at the following time points: before induction of the anaesthesia; before the surgical procedure when the induction is terminated and recruitment manoeuvers have been performed; after the termination of the surgical procedure; before transport to the Post anaesthesia Care Unit (PACU); before the discharge from the PACU after 2 hours of monitoring. An additional thoracic EIT-measurement will be performed before discharge at home. For this, resulting potential differences are measured, and impedance distribution sampled at 30 Hz will be calculated. Relative change in poorly ventilated lung regions (silent spaces) and end-expiratory lung impedance (EELI) and measures of ventilation inhomogeneity will be calculated using customised code (Matlab R2021a, The MathWorks, Nattick, Massachusetts, USA).

Eligibility Criteria

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

Study Population

The investigators will include obese patients exceeding body mass index (BMI) 40, scheduled for laparoscopic bariatric surgery at the University Hospital - Inselspital in Bern

You may qualify if:

• BMI \>40
• ASA physical status 1 to 4
• Over 18 years of age providing written informed consent

You may not qualify if:

• BMI \<40
• Known severe pulmonary hypertension,
• Need of home oxygen therapy
• Known heart failure
• Suspected, or known recent pulmonal infections

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias Braun, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: October 19, 2021
• Primary Completion: November 1, 2022
• Study Completion: March 8, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)