Clinical trial NCT02779998: Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology
Official title: Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Electrophysiology
Anesthesia
Acute Respiratory Failure
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory event
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
Secondary outcomes:
measure: Occurence of hemodynamic instability
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
measure: Respiratory rate
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
measure: End-Tidal carbon dioxygen
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
measure: Tidal Volume
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
measure: Respiratory settings of NIV ventilator
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
measure: O2 inspiration fraction
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
measure: Bispectral Index variability
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
measure: Occurence of a major medical event
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
measure: Occurence of a minor medical event
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
measure: Procedure failure
timeFrame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours)
measure: Patient status
timeFrame: within 7 days after procedure
measure: Length of hospital stay
timeFrame: within 7 days after procedure
measure: Length of Intensive Care Unit (ICU) stay
timeFrame: within 7 days after procedure
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Grenoble University Hospital
Study officials:
References: