Acute Respiratory Failure, Anesthesia, Cardiac Electrophysiology
Conditions
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.
Interventions
OTHERnon 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%.
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate | 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 |
| Tidal Volume | 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 |
| 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 |
| 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. |
| 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 |
| 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 | — |
| 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 |
Countries
France
Outcome results
None listed