Impact of LPV During OFA on Postoperative Oxygen Saturation.

• Conditions: Oxygen Saturation
• Interventions: Procedure: LPV; Procedure: routine LV

• Registration Number: NCT04192305
• Lead Sponsor: AZ Sint-Jan AV

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)

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-01
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-06
• Last Update Submitted: 2019-12-06
• Study First Posted: 2019-12-10
• Last Update Posted: 2019-12-10
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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%.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lung protective ventilation (LPV)	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)	routine LV	ventilation and adapting PEEP, LRM and oxygen only when saturation drops.

Primary Outcome Measures

Name	Time	Method
postoperative oxygen saturation	up to maximum 4 hours	saturation is continuously measured in the post anesthetic area without giving oxygen until sat drops below 94%.

Trial Locations

Locations (1)

Azsintjan; 🇧🇪 Brugge, Belgium