Bariatric Electrical Impedance Tomography

• Sponsor: University Hospital Inselspital, Berne (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05187039
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 8.4
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Other: Electrical impedance tomography during anesthesia

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 Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Atelectasis Formation and Regression With Electrical Impedance Tomography in the Perioperative Phase of Obese Patients Scheduled for Laparoscopic Bariatric Surgery
• Actual Study Start Date: Oct 19, 2021
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Outcome Measures

Primary Outcome Measures

1. Proportion of poorly ventilated lung areas (silent spaces) [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).

Secondary Outcome Measures

1. EIT-Measurement after the end of induction before the surgical procedure [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. EIT-Measurement at the end of the surgical procedure [5 minutes after Capnoperitoneum]

   Detection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)

3. 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.]

   Detection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)

4. EIT-Measurement before discharge from the PACU [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)

5. EIT-Measurement before discharging the patient at home [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)

6. Duration of surgical procedure. [Up to 90 to 150 minutes]

   Duration of surgical procedure.

7. Duration of anaesthesia [Up to 90 to 180 minutes]

   Duration of anaesthesia

8. Desaturation below 90%. [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

9. Follow up at 14 days [14 days]

   Follow-up by phone, regarding respiratory complications or need for rehospitalization.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Bern	Bern		Switzerland	3010

Sponsors and Collaborators

• University Hospital Inselspital, Berne

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT05187039
• Other Study ID Numbers: 2021-01473
• First Posted: Jan 11, 2022
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital Inselspital, Berne: Bariatric; Obese; Laparoscopic; Electrical impedance tomography
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Jan 27, 2022