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COMPLETEDNANCT02779998

Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology

Acute respiratory failure is frequent during rhythmology procedure under light sedation in high risks selected patients. Non invasive ventilation (NIV) is recommended for acute cardiogenic pulmonary o...

Lead sponsor: University Hospital, Grenoble•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University Hospital, Grenoble

This study is an investigator-initiated, monocentric, two-arm parallel-group trial with electronic system based randomization. The study protocol was approved by a Central Ethics Committee (France) according to French law. Our teaching hospital have a long experience with peroperative use of NIV during light sedation and acute respiratory failure. This study is designed as a PROBE study (Prospective Randomized Open with Blinded Evaluation) : the investigators will provide a blinded analysis of peroperative computer collected data.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Age of 18 years old or above
•Procedure in electrophysiology laboratory
•High risk patient defined by an American Society of Anesthesiology (ASA) score of 3 or 4

Exclusion Criteria

•Planned orotracheal intubation
•ASA 1 or 2
•Sleep apnea treated with home non invasive ventilation
•Major contraindication to NIV use
•Pregnancy
•Consent refusal
•Patients protected under the French Law L1121-5 to L1121-8

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 5, 2020Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment200

Start dateJan 2017

Last updatedNov 5, 2020

Condition

Cardiac Electrophysiology Anesthesia Acute Respiratory Failure

Locations shown

Grenoble University Hospital

La Tronche

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2020Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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