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Completed

NCT Number: NCT02779998

Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology

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.

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Key information

Conditions

Cardiac Electrophysiology Acute Respiratory Failure Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble University Hospital

La Tronche, 38700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%.

Standard oxygen therapy with facial mask

Other

Primary outcomes

  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 outcomes

  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 canula,

    • 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: VNI-RYTHMO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 23, 2016
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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