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Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy

Primary Purpose

Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxygen administration with Common nasal cannula
Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel
Sponsored by
Hospital Son Espases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Disease focused on measuring Children, Desaturations, Bronchoscopy, Oxygen, High flow oxygen

Eligibility Criteria

29 Days - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elective flexible bronchoscopy

Exclusion Criteria:

  • admitted in Neonatal intensive care
  • previous respiratory support: oxygen any device, non invasive or invasive ventilation
  • patient who may benefit with continuous positive pressure during procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Common nasal cannula

    High flow nasal cannula

    Arm Description

    Oxygen administration up to 4 liters according defined protocol

    Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study

    Outcomes

    Primary Outcome Measures

    Oxygen desaturation
    Number of patients with Oxygen saturation under 94% during bronchoscopy

    Secondary Outcome Measures

    Moderate oxygen desaturations
    Number of patients with Oxygen saturation < 94% and > 90 %
    Severe oxygen desaturations
    Number of patients with Oxygen saturation< 90%
    Tachypnea
    Number of patients with Breath rate more than p95 fore age for more than 30 seconds
    Apnea
    Number of patients with Breath rate 0 for more than 20 seconds or recure intervention
    Bradycardia
    Number of patients with Heart rate less than p5 forte age for more than 20 seconds

    Full Information

    First Posted
    May 30, 2019
    Last Updated
    June 6, 2019
    Sponsor
    Hospital Son Espases
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03976167
    Brief Title
    Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy
    Official Title
    Oxygen Administration During Bronchoscopy in Children, High Flow and Common Nasal Cannula: a Randomized Controled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 10, 2015 (Actual)
    Primary Completion Date
    February 28, 2019 (Actual)
    Study Completion Date
    February 28, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital Son Espases

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Disease
    Keywords
    Children, Desaturations, Bronchoscopy, Oxygen, High flow oxygen

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    108 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Common nasal cannula
    Arm Type
    Active Comparator
    Arm Description
    Oxygen administration up to 4 liters according defined protocol
    Arm Title
    High flow nasal cannula
    Arm Type
    Experimental
    Arm Description
    Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study
    Intervention Type
    Device
    Intervention Name(s)
    Oxygen administration with Common nasal cannula
    Intervention Description
    Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.
    Intervention Type
    Device
    Intervention Name(s)
    Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel
    Primary Outcome Measure Information:
    Title
    Oxygen desaturation
    Description
    Number of patients with Oxygen saturation under 94% during bronchoscopy
    Time Frame
    Trough study completion, an average of 2 years
    Secondary Outcome Measure Information:
    Title
    Moderate oxygen desaturations
    Description
    Number of patients with Oxygen saturation < 94% and > 90 %
    Time Frame
    Trough study completion, an average of 2 years
    Title
    Severe oxygen desaturations
    Description
    Number of patients with Oxygen saturation< 90%
    Time Frame
    Trough study completion, an average of 2 years
    Title
    Tachypnea
    Description
    Number of patients with Breath rate more than p95 fore age for more than 30 seconds
    Time Frame
    Trough study completion, an average of 2 years
    Title
    Apnea
    Description
    Number of patients with Breath rate 0 for more than 20 seconds or recure intervention
    Time Frame
    Trough study completion, an average of 2 years
    Title
    Bradycardia
    Description
    Number of patients with Heart rate less than p5 forte age for more than 20 seconds
    Time Frame
    Trough study completion, an average of 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    29 Days
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: elective flexible bronchoscopy Exclusion Criteria: admitted in Neonatal intensive care previous respiratory support: oxygen any device, non invasive or invasive ventilation patient who may benefit with continuous positive pressure during procedure
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Artur sharluyan, MD
    Organizational Affiliation
    Ib-salut
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sebastian Sailer, MD
    Organizational Affiliation
    Ib-salud
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Francisco de Borja Osona Rodriguez, PhD
    Organizational Affiliation
    Ib-salud
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34506689
    Citation
    Sharluyan A, Osona B, Frontera G, Brandstrup KB, Figuerola J, Sanz-Ruiz I, Salas A, Garrido B, Eva CG, Fernandez A, Pena-Zarza JA, Gil JA, Bover-Bauza C, Sailer S. High flow nasal cannula versus standard low flow nasal oxygen during flexible bronchoscopy in children: A randomized controlled trial. Pediatr Pulmonol. 2021 Dec;56(12):4001-4010. doi: 10.1002/ppul.25655. Epub 2021 Sep 10.
    Results Reference
    derived

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    Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy

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