Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology (VNI-RYTHMO)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Acute Respiratory Failure; Cardiac Electrophysiology; Anesthesia

Treatments: Other: Standard oxygen therapy with facial mask; Other: non invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02779998

38RC15.163

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

standard oxygen therapy with facial mask

Active Comparator group

Description:

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.

Treatment:

Other: Standard oxygen therapy with facial mask

non invasive ventilation

Experimental group

Description:

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%.

Treatment:

Other: non invasive ventilation