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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05187039
Other study ID # 2021-01473
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 19, 2021
Est. completion date March 8, 2023

Study information

Verified date March 2023
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 8, 2023
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Electrical impedance tomography during anesthesia
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).

Locations

Country Name City State
Switzerland University Hospital Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 EIT-Measurement after the end of induction before the surgical procedure 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
Secondary EIT-Measurement at the end of the surgical procedure Detection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT) 5 minutes after Capnoperitoneum
Secondary EIT-Measurement 2 minutes after the end of anaesthesia, before the transport in 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.
Secondary EIT-Measurement before discharge from the 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
Secondary EIT-Measurement before discharging the patient at home 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
Secondary Duration of surgical procedure. Duration of surgical procedure. Up to 90 to 150 minutes
Secondary Duration of anaesthesia Duration of anaesthesia Up to 90 to 180 minutes
Secondary Desaturation below 90%. 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
Secondary Follow up at 14 days Follow-up by phone, regarding respiratory complications or need for rehospitalization. 14 days
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