Bariatric Electrical Impedance Tomography

March 8, 2023 updated by: University Hospital Inselspital, Berne

Evaluation of Atelectasis Formation and Regression With Electrical Impedance Tomography in the Perioperative Phase of Obese Patients Scheduled for Laparoscopic Bariatric Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible patients with written informed consent, scheduled for laparoscopic bariatric surgery. As for standard of care no premedication will be given for bariatric patients. Patients will be monitored according the local standard.

Thoracic electrical impedance tomography measurements (each measurement will last 1 min) 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 electrical impedance tomography measurement (duration 1 min) will be performed before discharge at home. For this, resulting potential differences are measured, and impedance distribution sampled at 30 Hz will be calculated by an automated linearized Newton-Raphson reconstruction algorithm. Relative change in poorly ventilated lung regions (silent spaces) and end-expiratory lung impedance (EELI) and measures of ventilation inhomogeneity such as the global inhomogeneity index will be calculated.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of poorly ventilated lung areas (silent spaces)
Time Frame: 2 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
EIT-Measurement after the end of induction before the surgical procedure
Time Frame: 2 minutes after the end of anesthesia induction
Detection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)
2 minutes after the end of anesthesia induction
EIT-Measurement at the end of the surgical procedure
Time Frame: 5 minutes after Capnoperitoneum
Detection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)
5 minutes after Capnoperitoneum
EIT-Measurement 2 minutes after the end of anaesthesia, before the transport in PACU
Time Frame: 2 minutes after the end of anaesthesia, before the transport to PACU.
Detection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)
2 minutes after the end of anaesthesia, before the transport to PACU.
EIT-Measurement before discharge from the PACU
Time Frame: Two hours after admission of the patient at PACU, before first mobilisation and before discharge from PACU
Detection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)
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
Time Frame: At hospital discharge, up to 3 days
Detection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)
At hospital discharge, up to 3 days
Duration of surgical procedure.
Time Frame: Up to 90 to 150 minutes
Duration of surgical procedure.
Up to 90 to 150 minutes
Duration of anaesthesia
Time Frame: Up to 90 to 180 minutes
Duration of anaesthesia
Up to 90 to 180 minutes
Desaturation below 90%.
Time Frame: During anaesthesia monitoring, from 1 to 10 minutes
Difference of formation and course of silent lung areas in patients with and without pre-existing CPAP-therapy
During anaesthesia monitoring, from 1 to 10 minutes
Follow up at 14 days
Time Frame: 14 days
Follow-up by phone, regarding respiratory complications or need for rehospitalization.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Matthias Braun, MD, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2021

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

March 8, 2023

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

December 21, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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