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

August 3, 2020 updated by: Adam Ogna, Centre Hospitalier Universitaire Vaudois
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Service de Pneumologie - Centre Hospitalier Universitaire Vaudois
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alban Lovis, MD
        • Sub-Investigator:
          • Adam OGNA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low - High frequence sequence
High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 250/min and respiratory rate 500/min
Device: High-frequency non-invasive ventilation
Comparison of 2 different settings of HF-NIV
Other Names:
  • HF-NIV
Experimental: High - Low frequence sequence
High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 500/min and respiratory rate 250/min
Device: High-frequency non-invasive ventilation
Comparison of 2 different settings of HF-NIV
Other Names:
  • HF-NIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of apnea
Time Frame: 1 study session (2 hours)
Duration of apnea according to the different settings of the HF-NIV, defined as absence of thoraco-abdominal respiratory movements
1 study session (2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcutaneous carbon dioxide partial pressure
Time Frame: 1 study session (2 hours)
Evolution of transcutaneous carbon dioxide partial pressure (TcCo2)
1 study session (2 hours)
Oxygen saturation of arterial blood
Time Frame: 1 study session (2 hours)
Evolution of oxygen saturation, measured by pulse-oximetry (SatO2)
1 study session (2 hours)
Lung volume
Time Frame: 1 study session (2 hours)
Evolution of lung volume
1 study session (2 hours)
Subjective tolerance
Time Frame: 1 study session (2 hours)
Subjective tolerance of the HF-NIV (questionnaire)
1 study session (2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Alban Lovis, Service de Pneumologie - CHUV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (Estimate)

March 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANIV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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