Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Respiratory event
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Respiratory event
Time Frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Based on computer analysis: * Hypoxia (pulse oxymetry below 90%) * Apnea (No respiratory cycle measured by End-Tidal carbon dioxygen (CO2) for more than 20 seconds)
Secondary Outcomes
- Occurence of hemodynamic instability(during procedure in cardiac electrophysiology laboratory (an average of 2 hours))
- Respiratory rate(during procedure in cardiac electrophysiology laboratory (an average of 2 hours))
- Occurence of a minor medical event(during procedure in cardiac electrophysiology laboratory (an average of 2 hours))
- Tidal Volume(during procedure in cardiac electrophysiology laboratory (an average of 2 hours))
- O2 inspiration fraction(during procedure in cardiac electrophysiology laboratory (an average of 2 hours))
- Bispectral Index variability(during procedure in cardiac electrophysiology laboratory (an average of 2 hours))
- End-Tidal carbon dioxygen(during procedure in cardiac electrophysiology laboratory (an average of 2 hours))
- Respiratory settings of NIV ventilator(during procedure in cardiac electrophysiology laboratory (an average of 2 hours))
- Occurence of a major medical event(during procedure in cardiac electrophysiology laboratory (an average of 2 hours))
- Procedure failure(during procedure in cardiac electrophysiology laboratory (an average of 2 hours))
- Patient status(within 7 days after procedure)
- Length of hospital stay(within 7 days after procedure)
- Length of Intensive Care Unit (ICU) stay(within 7 days after procedure)