Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology

NCT ID: NCT02779998

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-12-31

Brief Summary

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 oedema and sleep apnea. The investigators will perform a monocentric, prospective, randomized controlled trial to compare the efficacy of NIV which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in prevention of peroperative respiratory event. Our hypothesis is that peroperative use of NIV should reduce the incidence of apnea and hypoxia during procedure in rhythmology under light sedation.

Detailed Description

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.

Conditions

Cardiac Electrophysiology; Anesthesia; Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

standard oxygen therapy with facial mask

Patients assigned to standard medical therapy will received supplemental oxygen via a facial Venturi mask at a rate of up to 15 liters per minute in order to maintain peripheral oxygen saturation (SpO2) above 94% during electrophysiology procedure under light sedation.

Group Type: ACTIVE_COMPARATOR

Standard oxygen therapy with facial mask

Intervention Type: OTHER

non invasive ventilation

non invasive ventilation (NIV) which associated positive end expiratory pressure (PEEP: 5 to 10 cmH2O) and pressure support ventilation (PSV: 5 to 15 cmH2O, to achieve total Pressure bellow 20cmH2O) will be delivered during electrophysiology procedure under light sedation. The patient will received supplemental oxygen through facial mask to achieve an oxygen saturation level above 94%.

Group Type: EXPERIMENTAL

non invasive ventilation

Intervention Type: OTHER

non invasive ventilation is delivered by a specific respirator with inspiratory help mode. NIV mask and parameters are adapted to obtains a Tidal volume ≤ to 8 ml/kg/cycle (if possible ≤ 6 ml/kg/cycle) and a SpO2 superior of 94%.

Interventions

non invasive ventilation

non invasive ventilation is delivered by a specific respirator with inspiratory help mode. NIV mask and parameters are adapted to obtains a Tidal volume ≤ to 8 ml/kg/cycle (if possible ≤ 6 ml/kg/cycle) and a SpO2 superior of 94%.

Intervention Type: OTHER

Standard oxygen therapy with facial mask

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grenoble University Hospital

La Tronche, , France

Countries

France

References

Moury PH, Pasquier V, Greco F, Arvieux JL, Alves-Macedo S, Richard M, Casez-Brasseur M, Skaare K, Jacon P, Durand M, Bedague D, Jaber S, Bosson JL, Albaladejo P. A randomized controlled trial of the intraoperative use of noninvasive ventilation versus supplemental oxygen by face mask for procedural sedation in an electrophysiology laboratory. Can J Anaesth. 2023 Jul;70(7):1182-1193. doi: 10.1007/s12630-023-02495-2. Epub 2023 Jun 2.

Reference Type: DERIVED

PMID: 37268802 (View on PubMed)

Other Identifiers

38RC15.163

Identifier Type: -

Identifier Source: org_study_id