NCT03929055

Brief Summary

The purpose of this study is to assess the effect of HFNC on esophageal pressure and diaphragmatic function in patients with acute respiratory failure

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
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

3.4 years

First QC Date

April 20, 2019

Last Update Submit

November 3, 2020

Conditions

Acute Respiratory FailureDiaphragmatic FunctionEsophageal Pressure

Outcome Measures

Primary Outcomes (1)

  • effects of HFNC on esophageal pressure variation

    the esophageal pressure will be measure using an esophageal ballon catheter. A decrease in esophageal pressure variation during HFNC treatment compared with CPAP

    one day

Secondary Outcomes (1)

  • effect of HFNC on diaphragmatic function

    one day

Study Arms (3)

venturi mask

ACTIVE COMPARATOR

oxygen is delivered by venturi mask to achieve peripheral oxygen saturation of al least 92%

Device: Physiological assesment

HFNC

ACTIVE COMPARATOR

HFNC is set to obtain the same oxygen fraction of venturi mask and flow of 40l/min

Device: Physiological assesment

CPAP

ACTIVE COMPARATOR

Helmet CPAP is set to obtain the same esophageal pressure variation during HFNC step

Device: Physiological assesment

Interventions

Physiological assesmentDEVICE

1. Arterial blood gas analysis. 2. esophageal pressure variation during inspiration and expiration 3. Arterial blood pressure, central venous pressure (CVP), heart rate. 4. diaphragmatic contraction detected by ultrasound

CPAPHFNCventuri mask

Eligibility Criteria

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

You may qualify if:

  • patient with acute respiratory failure, not intubated, who require non invasive mechanical ventilation

You may not qualify if:

  • patients in which it is not possible to place the esophageal catheter or it is not possible to detect the diaphragm by ultrasound or it is not possible to apply the nasal cannula device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST-Santi Paolo e Carlo, San Paolo Hospital

Milan, 20142, Italy

RECRUITING

Study Design

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

Study Record Dates

First Submitted

April 20, 2019

First Posted

April 26, 2019

Study Start

January 1, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

IT(1)