Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology

Not Applicable

Completed

• Conditions: Acute Respiratory Failure; Cardiac Electrophysiology; Anesthesia
• Interventions: Other: Standard oxygen therapy with facial mask; Other: non invasive ventilation

• Registration Number: NCT02779998
• Lead Sponsor: University Hospital, Grenoble

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 Timeline

• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-23
• Study Start: 2017-01
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard oxygen therapy with facial mask	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.
non invasive ventilation	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%.

Primary Outcome Measures

Name	Time	Method
Respiratory event	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 Outcome Measures

Name	Time	Method
Occurence of hemodynamic instability	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)	Based on computer analysis and defined as: low blood pressure or bradycardia with need of catecholamine drugs or volume resuscitation.
Respiratory rate	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)	Based on computer analysis
Occurence of a minor medical event	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)	A minor medical event is defined as; * NIV mask related skin injuries,; * nausea or vomiting,; * aspiration; Guedel canula,; - mandibular subluxation
Tidal Volume	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)	Based on computer analysis
O2 inspiration fraction	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)	Based on computer analysis
Bispectral Index variability	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)	Based on computer analysis
End-Tidal carbon dioxygen	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)	Based on computer analysis
Respiratory settings of NIV ventilator	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)	Based on computer analysis
Occurence of a major medical event	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)	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
Procedure failure	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)	Procedure failure is defined as the change of oxygen device or the change of ventilatory mode (controlled mode)
Patient status	within 7 days after procedure	A composite outcome defined as the occurence of: * death,; * cardiac complication (acute heart failure, infarcts),; * acute respiratory failure; * pneumopathy
Length of hospital stay	within 7 days after procedure
Length of Intensive Care Unit (ICU) stay	within 7 days after procedure

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 La Tronche, France