Impact of LPV During OFA on Postoperative Oxygen Saturation.

NCT ID: NCT04192305

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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)

Conditions

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Oxygen Saturation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

LPV

Intervention Type PROCEDURE

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 lung ventilation (LV)

ventilation and adapting PEEP, LRM and oxygen only when saturation drops.

routine LV

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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%.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

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Jan Mulier

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Paul Mulier

Role: PRINCIPAL_INVESTIGATOR

AZSint Jan AV

Locations

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Azsintjan

Bruges, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Jan Paul Mulier

Role: CONTACT

Phone: +32486729203

Email: [email protected]

Mulier

Role: CONTACT

Other Identifiers

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OS impact LPV on SAT d OFA

Identifier Type: -

Identifier Source: org_study_id