Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology

Anesthesia Clinical Trial

— VNI-RYTHMO  

Official title:

Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779998
• Other study ID #: 38RC15.163
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: November 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Anesthesia
• Cardiac Electrophysiology
• Respiratory Insufficiency

Intervention

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%.
• Standard oxygen therapy with facial mask

Locations

Country	Name	City	State
France	Grenoble University Hospital	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Respiratory rate	Based on computer analysis	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Secondary	End-Tidal carbon dioxygen	Based on computer analysis	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Secondary	Tidal Volume	Based on computer analysis	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Secondary	Respiratory settings of NIV ventilator	Based on computer analysis	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Secondary	O2 inspiration fraction	Based on computer analysis	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Secondary	Bispectral Index variability	Based on computer analysis	during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Length of hospital stay		within 7 days after procedure
Secondary	Length of Intensive Care Unit (ICU) stay		within 7 days after procedure