Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology

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.

Official Title
-----------------
Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology

Conditions
-----------------
Cardiac Electrophysiology, Anesthesia, Acute Respiratory Failure

Intervention / Treatment
-----------------
* Other: non invasive ventilation
* Other: Standard oxygen therapy with facial mask


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard oxygen therapy with facial mask<br>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. | Other: Standard oxygen therapy with facial mask<br> <br> |
| Experimental: non invasive ventilation<br>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%. | Other: non invasive ventilation<br>* 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%.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory event | 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) | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of hemodynamic instability | Based on computer analysis and defined as: low blood pressure or bradycardia with need of catecholamine drugs or volume resuscitation. | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 
| Respiratory rate | Based on computer analysis | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 
| End-Tidal carbon dioxygen | Based on computer analysis | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 
| Tidal Volume | Based on computer analysis | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 
| Respiratory settings of NIV ventilator | Based on computer analysis | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 
| O2 inspiration fraction | Based on computer analysis | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 
| Bispectral Index variability | Based on computer analysis | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 
| Occurence of a major medical event | A major medical event is defined as pneumothorax, oro-tracheal intubation or laryngeal mask, cardiopulmonary resuscitation, surgical complication pleural or pericardia effusion drain use Intervention from anesthesiologist | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 
| Occurence of a minor medical event | A minor medical event is defined as NIV mask related skin injuries, nausea or vomiting, aspiration Guedel canula, - mandibular subluxation | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 
| Procedure failure | Procedure failure is defined as the change of oxygen device or the change of ventilatory mode (controlled mode) | during procedure in cardiac electrophysiology laboratory (an average of 2 hours) | 
| Patient status | A composite outcome defined as the occurence of: death, cardiac complication (acute heart failure, infarcts), acute respiratory failure pneumopathy | 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 |