Impact of LPV During OFA on Postoperative Oxygen Saturation.
Observational Study Evaluating the Impact of Lung Protective Ventilation (LPV) During Opioid Free Anesthesia (OFA) on Postoperative Oxygen Saturation.
1 other identifier
observational
100
1 country
1
Brief Summary
Observational study comparing patients with lung protective ventilation (LPV) following the consensus guidelines by Young C with patients getting routine lung ventilation, both during opioid free anesthesia (OFA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 2, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 10, 2019
December 1, 2019
1 year
December 2, 2019
December 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative oxygen saturation
saturation is continuously measured in the post anesthetic area without giving oxygen until sat drops below 94%.
up to maximum 4 hours
Study Arms (2)
lung protective ventilation (LPV)
lung protective ventilation low tidal volume, minimum PEEP and higher PEEP and lung recruitment based on total lung compliance, low inspiratory oxygen concentration and CPAP during extubation without prior suctioning inside the endotracheal tube.
routine lung ventilation (LV)
ventilation and adapting PEEP, LRM and oxygen only when saturation drops.
Interventions
LPV means tidal volume of 6 ml/kg, inspiratory-expiratory (I/E) ratio of 1/1, positive end expiratory pressure (PEEP) minimum 5 cmH20 and higher during laparoscopy in obese patients, Inspiratory oxygen concentration (FIO2) 40 % during maintenance and extubation while also giving CPAP. Lung recruitment maneuver (LRM) when lung compliance decreases below 40 ml/cmH2O.
Give volume en frequency as required by end tidal carbon dioxide, PEEP and LRM only when saturation drops intra operative, no requirement to use low FIO2 and CPAP during extubation.
Eligibility Criteria
bariatric surgery is performed in obese patients with BMI \> 35
You may qualify if:
- bariatric surgery
- morbid obesity ( BMI \> 35)
You may not qualify if:
- patients with pre existing severe cardio-pulmonary diseases having oxygen saturation without oxygen below 94%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AZ Sint-Jan AVlead
Study Sites (1)
Azsintjan
Bruges, 8000, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Paul Mulier
AZSint Jan AV
Central Study Contacts
Mulier
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
December 2, 2019
First Posted
December 10, 2019
Study Start
December 1, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
December 10, 2019
Record last verified: 2019-12