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Efficacy of High Velocity Nasal Insufflation

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ClinicalTrials.gov Identifier: NCT03929055
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, University of Milan

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

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Diaphragmatic Function Esophageal Pressure Device: Physiological assesment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of High Velocity Nasal Insufflation Compared With Venturi Mask and Helmet CPAP in Acute Respiratory Failure
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020


Arm Intervention/treatment
Active Comparator: venturi mask
oxygen is delivered by venturi mask to achieve peripheral oxygen saturation of al least 92%
Device: Physiological assesment
  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

Active Comparator: HFNC
HFNC is set to obtain the same oxygen fraction of venturi mask and flow of 40l/min
Device: Physiological assesment
  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

Active Comparator: CPAP
Helmet CPAP is set to obtain the same esophageal pressure variation during HFNC step
Device: Physiological assesment
  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




Primary Outcome Measures :
  1. effects of HFNC on esophageal pressure variation [ Time Frame: one day ]
    the esophageal pressure will be measure using an esophageal ballon catheter. A decrease in esophageal pressure variation during HFNC treatment compared with CPAP


Secondary Outcome Measures :
  1. effect of HFNC on diaphragmatic function [ Time Frame: one day ]
    the diaphragmatic function will be detected using the ultrasound. An improvement in diaphragmatic contractility function as detected by the increase in its thickness ratio is expected during HFNC treatment compared with CPAP



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929055


Locations
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Italy
ASST-Santi Paolo e Carlo, San Paolo Hospital Recruiting
Milan, Italy, 20142
Contact: Davide Chiumello    +390281844020    chiumello@libero.it   
Sponsors and Collaborators
University of Milan

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Responsible Party: Davide Chiumello, Prof, University of Milan
ClinicalTrials.gov Identifier: NCT03929055     History of Changes
Other Study ID Numbers: HFNC
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases