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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
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%.
Grenoble University Hospital
La Tronche, France
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)
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Occurence of hemodynamic instability
Based on computer analysis and defined as: low blood pressure or bradycardia with need of catecholamine drugs or volume resuscitation.
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Respiratory rate
Based on computer analysis
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
End-Tidal carbon dioxygen
Based on computer analysis
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Tidal Volume
Based on computer analysis
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Respiratory settings of NIV ventilator
Based on computer analysis
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
O2 inspiration fraction
Based on computer analysis
Time frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Bispectral Index variability
Based on computer analysis
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: within 7 days after procedure
Length of hospital stay
Time frame: within 7 days after procedure
Length of Intensive Care Unit (ICU) stay
Time frame: within 7 days after procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.