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Clinical Trials/NCT04192305
NCT04192305
Unknown
N/A

Observational Study Evaluating the Impact of Lung Protective Ventilation (LPV) During Opioid Free Anesthesia (OFA) on Postoperative Oxygen Saturation.

AZ Sint-Jan AV1 site in 1 country100 target enrollmentDecember 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Oxygen Saturation
Sponsor
AZ Sint-Jan AV
Enrollment
100
Locations
1
Primary Endpoint
postoperative oxygen saturation
Last Updated
6 years ago

Overview

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).

Detailed Description

The paper by C Young et al describes the essential steps in protecting the lungs and preventing post operative pulmonary complications (PPC) like alveolar collapse. Alveolar collapse can be measured by oxygen saturation drop when no oxygen therapy is given, when full neuromuscular block (NMB) reversal and no opioid is given intra and postoperative. 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) max 80% during induction and max 40 % during maintenance and extubation. Extubation in an awake, full NMB reversed patient getting no opioids while giving continuous positive airway pressure (CPAP) during withdrawal of the tube. Lung recruitment maneuver (LRM) when lung compliance decreases below 40 milliliter per centimeter water. (ml/cmH2O)

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
December 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jan Mulier

MD PhD

AZ Sint-Jan AV

Eligibility Criteria

Inclusion Criteria

  • bariatric surgery
  • morbid obesity ( BMI \> 35)

Exclusion Criteria

  • patients with pre existing severe cardio-pulmonary diseases having oxygen saturation without oxygen below 94%.

Outcomes

Primary Outcomes

postoperative oxygen saturation

Time Frame: up to maximum 4 hours

saturation is continuously measured in the post anesthetic area without giving oxygen until sat drops below 94%.

Study Sites (1)

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