NCT02779998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

May 12, 2016

Last Update Submit

November 4, 2020

Conditions

Cardiac ElectrophysiologyAnesthesiaAcute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Respiratory event

    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)

    during procedure in cardiac electrophysiology laboratory (an average of 2 hours)

Secondary Outcomes (13)

  • Occurence of hemodynamic instability

    during procedure in cardiac electrophysiology laboratory (an average of 2 hours)

  • Respiratory rate

    during procedure in cardiac electrophysiology laboratory (an average of 2 hours)

  • End-Tidal carbon dioxygen

    during procedure in cardiac electrophysiology laboratory (an average of 2 hours)

  • Tidal Volume

    during procedure in cardiac electrophysiology laboratory (an average of 2 hours)

  • Respiratory settings of NIV ventilator

    during procedure in cardiac electrophysiology laboratory (an average of 2 hours)

  • +8 more secondary outcomes

Study Arms (2)

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.

Other: Standard oxygen therapy with facial mask

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%.

Other: non invasive ventilation

Interventions

non invasive ventilationOTHER

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%.

non invasive ventilation
Standard oxygen therapy with facial maskOTHER
standard oxygen therapy with facial mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

La Tronche, 38700, France

Location

Related Publications (1)

  • 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.

    PMID: 37268802DERIVED

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 23, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

FR(1)