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Bariatric Electrical Impedance Tomography

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05187039
Enrollment
30
Registered
2022-01-11
Start date
2021-10-19
Completion date
2023-03-08
Last updated
2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Bariatric, Obese, Laparoscopic, Electrical impedance tomography

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.

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.

Interventions

OTHERElectrical 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).

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of poorly ventilated lung areas (silent spaces)2 hoursProportion 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

MeasureTime frameDescription
EIT-Measurement at the end of the surgical procedure5 minutes after CapnoperitoneumDetection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)
EIT-Measurement 2 minutes after the end of anaesthesia, before the transport in PACU2 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)
EIT-Measurement before discharge from the PACUTwo hours after admission of the patient at PACU, before first mobilisation and before discharge from PACUDetection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)
EIT-Measurement before discharging the patient at homeAt hospital discharge, up to 3 daysDetection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)
EIT-Measurement after the end of induction before the surgical procedure2 minutes after the end of anesthesia inductionDetection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)
Duration of anaesthesiaUp to 90 to 180 minutesDuration of anaesthesia
Desaturation below 90%.During anaesthesia monitoring, from 1 to 10 minutesDifference of formation and course of silent lung areas in patients with and without pre-existing CPAP-therapy
Follow up at 14 days14 daysFollow-up by phone, regarding respiratory complications or need for rehospitalization.
Duration of surgical procedure.Up to 90 to 150 minutesDuration of surgical procedure.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026