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Completed

NCT Number: NCT05187039

Bariatric Electrical Impedance Tomography

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Duration of surgical procedure.

    Time frame: Up to 90 to 150 minutes

    Duration of surgical procedure.

  7. Duration of anaesthesia

    Time frame: Up to 90 to 180 minutes

    Duration of anaesthesia

  8. 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

  9. Follow up at 14 days

    Time frame: 14 days

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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 11, 2022
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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