To assess if preoxygenation with 100% O2 or preoxygenation with 100% O2 and PEEP are different with respect to the development of atelectasis as determined by lung computed tomography.
ID
Source
Brief title
Condition
- Other condition
- Respiratory disorders NEC
- Hepatobiliary therapeutic procedures
Synonym
Health condition
Anesthesiologische handelingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The % volume of atelectasis as determined by computed tomography (CT) images of
the lungs.
Secondary outcome
* Oxygenation levels
* Patient demographics (gender, age, ASA classification)
* IRE characteristics (duration of procedure)
* Anesthesia parameters (dosing of anesthetics, sedatives and analgesics)
* Ventilation parameters (FiO2, etCO2, etO2, tidal volume, ventilation
frequency, airway pressure, PEEP)
* Postoperative infections
Background summary
The presence of atelectasis is detrimental for lung ventilation and should
therefore be prevented. It is assumed that routine preoxygenation strategies
before the induction of anesthesia may contribute to the development of
atelectasis. The present research proposal aims to compare two different
preoxygenation strategies in order to evaluate whether the volume of
atelectasis may be reduced.
Study objective
To assess if preoxygenation with 100% O2 or preoxygenation with 100% O2 and
PEEP are different with respect to the development of atelectasis as determined
by lung computed tomography.
Study design
Single-blinded randomized controlled trial.
Intervention
Preoxygenation with 100% oxygen or 100% oxygen with positive end-expiratory
pressure
Study burden and risks
Preoxygenation with 100% oxygen in anesthesia is common, but associated with
atelectasis. The A group will therefore be exposed to 100% oxygen and the B
group will exposed to 100% oxygen in combination with positive end-expiratory
pressure (PEEP) in order to prevent atelectasis. Both oxygenation strategies
are part of the daily clinical practice of anesthesiologists. The burden of the
study includes 5-10 minutes additional CT scanning time, and a increased
exposure to irradiation of 0.2 mSv per single slice CT scan (= 1,4 mSv for a
total 7 scans). The mean irradiaton for a average IRE liver is 15-18 mSv.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing elective irreversible electroporation of the liver
Age 18-85 years
Informed consent
Exclusion criteria
Emergent surgery
ICU patients
COPD GOLD III/IV
Anticipated difficult airway
MP III/IV
Previously diagnosed with difficult airway.
Pre-existing atelectasis.
Lung lesions
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-003422-81-NL |
| CCMO | NL45968.029.13 |