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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04192305

Enrollment

100

Registered

2019-12-10

Start date

2019-12-01

Completion date

2021-12-31

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxygen Saturation

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)

Interventions

PROCEDURELPV

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.

PROCEDUREroutine LV

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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%.

Design outcomes

Primary

Measure	Time frame	Description
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%.

Countries

Belgium

Contacts

Primary ContactJan Paul Mulier

jan.mulier@azsintjan.be+32486729203

Backup ContactMulier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026