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Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology (VNI-RYTHMO)

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ClinicalTrials.gov Identifier: NCT02779998
Recruitment Status : Recruiting
First Posted : May 23, 2016
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Cardiac Electrophysiology Anesthesia Acute Respiratory Failure Other: non invasive ventilation Other: Standard oxygen therapy with facial mask Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology
Actual Study Start Date : January 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Active Comparator: standard oxygen therapy with facial mask
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.
Other: Standard oxygen therapy with facial mask
Experimental: non invasive ventilation
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%.
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%.




Primary Outcome Measures :
  1. Respiratory event [ Time Frame: 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 Outcome Measures :
  1. Occurence of hemodynamic instability [ Time Frame: 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.

  2. Respiratory rate [ Time Frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours) ]
    Based on computer analysis

  3. End-Tidal carbon dioxygen [ Time Frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours) ]
    Based on computer analysis

  4. Tidal Volume [ Time Frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours) ]
    Based on computer analysis

  5. Respiratory settings of NIV ventilator [ Time Frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours) ]
    Based on computer analysis

  6. O2 inspiration fraction [ Time Frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours) ]
    Based on computer analysis

  7. Bispectral Index variability [ Time Frame: during procedure in cardiac electrophysiology laboratory (an average of 2 hours) ]
    Based on computer analysis

  8. Occurence of a major medical event [ Time Frame: 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

  9. Occurence of a minor medical event [ Time Frame: 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 cannula,
    • mandibular subluxation

  10. Procedure failure [ Time Frame: 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)

  11. Patient status [ Time Frame: within 7 days after procedure ]

    A composite outcome defined as the occurence of:

    • death,
    • cardiac complication (acute heart failure, infarcts),
    • acute respiratory failure
    • pneumopathy

  12. Length of hospital stay [ Time Frame: within 7 days after procedure ]
  13. Length of Intensive Care Unit (ICU) stay [ Time Frame: within 7 days after procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779998


Contacts
Contact: Pierre Henri Moury, MD PHMoury@chu-grenoble.fr

Locations
France
Grenoble University Hospital Recruiting
La Tronche, France, 38700
Contact: Pierre Albaladejo, MD, PhD       PAlbaladejo@chu-grenoble.fr   
Sub-Investigator: pierre-henry Moury         
Sponsors and Collaborators
University Hospital, Grenoble

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02779998     History of Changes
Other Study ID Numbers: 38RC15.163
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases