NCT02712190

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

6.5 years

First QC Date

March 10, 2016

Last Update Submit

August 3, 2020

Conditions

Non-invasive VentilationHigh-frequency VentilationHealthy VolunteerLung Diseases

Outcome Measures

Primary Outcomes (1)

  • Duration of apnea

    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 Outcomes (4)

  • Transcutaneous carbon dioxide partial pressure

    1 study session (2 hours)

  • Oxygen saturation of arterial blood

    1 study session (2 hours)

  • Lung volume

    1 study session (2 hours)

  • Subjective tolerance

    1 study session (2 hours)

Study Arms (2)

Low - High frequence sequence

EXPERIMENTAL

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

High - Low frequence sequence

EXPERIMENTAL

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

Interventions

High-frequency non-invasive ventilationDEVICE

Comparison of 2 different settings of HF-NIV

Also known as: HF-NIV
High - Low frequence sequenceLow - High frequence sequence

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • increased pneumothorax risk under positive pressure ventilation
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pneumologie - Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Alban Lovis

    Service de Pneumologie - CHUV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alban Lovis, MD

CONTACT

alban.lovis@chuv.ch

Adam Ogna, MD

CONTACT

adam.ogna@chuv.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 18, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

August 5, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)