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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Acute Respiratory Failure; Cardiac Electrophysiology
• Intervention / Treatment: Other: Standard oxygen therapy with facial mask; Other: non invasive ventilation

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Tronche, France, 38700
    • Grenoble University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Standard oxygen therapy with facial mask
Experimental: 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%.	Other: 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%.

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 38RC15.163