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Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation. (ANIV)

Primary Purpose

Non-invasive Ventilation, High-frequency Ventilation, Healthy Volunteer

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
High-frequency non-invasive ventilation
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non-invasive Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy subjets : normal respiratory function and no known lung disease
  • lung disease patients : chronic obstructive pulmonary disease, Sarcoidosis, Cystic fibrosis
  • age >=18y

Exclusion Criteria:

  • increased pneumothorax risk under positive pressure ventilation
  • pregnancy

Sites / Locations

  • Service de Pneumologie - Centre Hospitalier Universitaire VaudoisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low - High frequence sequence

High - Low frequence sequence

Arm Description

High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 250/min and respiratory rate 500/min

High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 500/min and respiratory rate 250/min

Outcomes

Primary Outcome Measures

Duration of apnea
Duration of apnea according to the different settings of the HF-NIV, defined as absence of thoraco-abdominal respiratory movements

Secondary Outcome Measures

Transcutaneous carbon dioxide partial pressure
Evolution of transcutaneous carbon dioxide partial pressure (TcCo2)
Oxygen saturation of arterial blood
Evolution of oxygen saturation, measured by pulse-oximetry (SatO2)
Lung volume
Evolution of lung volume
Subjective tolerance
Subjective tolerance of the HF-NIV (questionnaire)

Full Information

First Posted
March 10, 2016
Last Updated
August 3, 2020
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT02712190
Brief Title
Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.
Acronym
ANIV
Official Title
Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to assess the efficacy of high-frequency non-invasive ventilation on apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung disease.
Detailed Description
High frequency ventilation (HF-V) allows to ensure oxygen delivery and carbon dioxide clearance despite the absence of thoracic movement in anesthetized, invasively ventilated subjects. This same technique could be applied by a non-invasive interface (HF-NIV), allowing to obtain a prolonged apnea (absence of thoraco-abdominal respiratory movements) in awaken subjects. Such an application would be of interest for several clinical applications, e.g. lung imaging and radio-therapy treatment on lung cancer. The purpose of the study is to assess the effect of different HF-NIV setting on the apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-invasive Ventilation, High-frequency Ventilation, Healthy Volunteer, Lung Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low - High frequence sequence
Arm Type
Experimental
Arm Description
High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 250/min and respiratory rate 500/min
Arm Title
High - Low frequence sequence
Arm Type
Experimental
Arm Description
High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 500/min and respiratory rate 250/min
Intervention Type
Device
Intervention Name(s)
High-frequency non-invasive ventilation
Other Intervention Name(s)
HF-NIV
Intervention Description
Comparison of 2 different settings of HF-NIV
Primary Outcome Measure Information:
Title
Duration of apnea
Description
Duration of apnea according to the different settings of the HF-NIV, defined as absence of thoraco-abdominal respiratory movements
Time Frame
1 study session (2 hours)
Secondary Outcome Measure Information:
Title
Transcutaneous carbon dioxide partial pressure
Description
Evolution of transcutaneous carbon dioxide partial pressure (TcCo2)
Time Frame
1 study session (2 hours)
Title
Oxygen saturation of arterial blood
Description
Evolution of oxygen saturation, measured by pulse-oximetry (SatO2)
Time Frame
1 study session (2 hours)
Title
Lung volume
Description
Evolution of lung volume
Time Frame
1 study session (2 hours)
Title
Subjective tolerance
Description
Subjective tolerance of the HF-NIV (questionnaire)
Time Frame
1 study session (2 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy subjets : normal respiratory function and no known lung disease lung disease patients : chronic obstructive pulmonary disease, Sarcoidosis, Cystic fibrosis age >=18y Exclusion Criteria: increased pneumothorax risk under positive pressure ventilation pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alban Lovis, MD
Email
alban.lovis@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Ogna, MD
Email
adam.ogna@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alban Lovis
Organizational Affiliation
Service de Pneumologie - CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Pneumologie - Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alban Lovis, MD
Email
alban.lovis@chuv.ch
First Name & Middle Initial & Last Name & Degree
Adam Ogna, MD
Email
adam.ogna@chuv.ch
First Name & Middle Initial & Last Name & Degree
Alban Lovis, MD
First Name & Middle Initial & Last Name & Degree
Adam Ogna, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.

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