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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard oxygen therapy with facial mask | Active Comparator | 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 | Experimental | 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non invasive ventilation | Other | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory event | Based on computer analysis:
| during procedure in cardiac electrophysiology laboratory (an average of 2 hours) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble University Hospital | La Tronche | 38700 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37268802 | Derived | Moury PH, Pasquier V, Greco F, Arvieux JL, Alves-Macedo S, Richard M, Casez-Brasseur M, Skaare K, Jacon P, Durand M, Bedague D, Jaber S, Bosson JL, Albaladejo P. A randomized controlled trial of the intraoperative use of noninvasive ventilation versus supplemental oxygen by face mask for procedural sedation in an electrophysiology laboratory. Can J Anaesth. 2023 Jul;70(7):1182-1193. doi: 10.1007/s12630-023-02495-2. Epub 2023 Jun 2. |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Standard oxygen therapy with facial mask | Other |
|
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
| during procedure in cardiac electrophysiology laboratory (an average of 2 hours) |
| Occurence of a minor medical event | A minor medical event is defined as
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:
| 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 |