AnesthesiaNCT05187039
Bariatric Electrical Impedance Tomography
An observational study of Anesthesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Electrical impedance tomography during anesthesia
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Oct 2021to 8 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- BMI >40
- ASA physical status 1 to 4
- Over 18 years of age providing written informed consent
Who cannot join
- BMI <40
- Known severe pulmonary hypertension,
- Need of home oxygen therapy
- Known heart failure
- Suspected, or known recent pulmonal infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Electrical impedance tomography during anesthesia
- Keywords
- Bariatric, Obese, Laparoscopic, Electrical impedance tomography
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomography during anesthesiaOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours
Secondary outcomes (9)
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)
Measured: 2 minutes after the end of anesthesia induction
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)
Measured: 5 minutes after Capnoperitoneum
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)
Measured: 2 minutes after the end of anaesthesia, before the transport to PACU.
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)
Measured: 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
Detection of changes in silent spaces, ventilation inhomogeneity and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT)
Measured: At hospital discharge, up to 3 days
Duration of surgical procedure.
Duration of surgical procedure.
Measured: Up to 90 to 150 minutes
Duration of anaesthesia
Duration of anaesthesia
Measured: Up to 90 to 180 minutes
Desaturation below 90%.
Difference of formation and course of silent lung areas in patients with and without pre-existing CPAP-therapy
Measured: During anaesthesia monitoring, from 1 to 10 minutes
Follow up at 14 days
Follow-up by phone, regarding respiratory complications or need for rehospitalization.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start19 Oct 2021
- Primary completion1 Nov 2022
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Braun, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187039
- Sponsor's protocol ID
- 2021-01473
- Status last verified
- Mar 2023
- First submitted
- 21 Dec 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Atelectasis Formation and Regression With Electrical Impedance Tomography in the Perioperative Phase of Obese Patients Scheduled for Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05187039
- Acronym / sponsor ID
- 2021-01473
- Conditions
- Anesthesia
- Keywords
- Bariatric, Obese, Laparoscopic, Electrical impedance tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- BMI >40
- ASA physical status 1 to 4
- Over 18 years of age providing written informed consent
Key exclusion criteria (5 listed)
- BMI <40
- Known severe pulmonary hypertension,
- Need of home oxygen therapy
- Known heart failure
- Suspected, or known recent pulmonal infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance tomography during anesthesiaThoracic 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). | Other | – |
Primary outcome
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).
9 secondary outcomes
EIT-Measurement after the end of induction before the surgical procedure
Time frame: 2 minutes after the end of anesthesia induction
EIT-Measurement at the end of the surgical procedure
Time frame: 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.
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
EIT-Measurement before discharging the patient at home
Time frame: At hospital discharge, up to 3 days
Duration of surgical procedure.
Time frame: Up to 90 to 150 minutes
Duration of anaesthesia
Time frame: Up to 90 to 180 minutes
Desaturation below 90%.
Time frame: During anaesthesia monitoring, from 1 to 10 minutes
Follow up at 14 days
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Braun, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of poorly ventilated lung areas (silent spaces) (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.