Impact of LPV During OFA on Postoperative Oxygen Saturation.

Oxygen Saturation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04192305
• Other study ID #: OS impact LPV on SAT d OFA
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: December 2019
• Source: AZ Sint-Jan AV
• Contact: Jan Paul Mulier
• Phone: +32486729203
• Email: jan.mulier[@]azsintjan.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%.

Related Conditions & MeSH terms

• Oxygen Saturation

Intervention

Procedure:
• LPV
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.
• routine 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.

Locations

Country	Name	City	State
Belgium	Azsintjan	Brugge

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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