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Helmet Ventilation in Acute Hypercapnic Respiratory Failure

Primary Purpose

Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Helmet (Starmed)
Total Face mask (Respironics)
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercapnic Respiratory Failure focused on measuring COPD, NIV, Acute Hypercapnic Respiratory Failure, COPD patients with hypercapnic respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • pH < 7,35 and PaCO2 > 45 mmHg
  • respiratory rate > 20 b/min

Exclusion Criteria:

  • hypoxic respiratory failure
  • coma
  • inability to stand NIV
  • lack of informed consent

Sites / Locations

  • Sant'Orsola malpighi Hospital
  • Sant'Orsola Malpighi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Helmet to deliver NIV

Total Face to deliver NIV

Arm Description

Outcomes

Primary Outcome Measures

Arterial Blood gases

Secondary Outcome Measures

Arterial Blood Gases

Full Information

First Posted
March 22, 2012
Last Updated
October 5, 2014
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT01645358
Brief Title
Helmet Ventilation in Acute Hypercapnic Respiratory Failure
Official Title
Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?"
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a "rotating" strategy when the facial mask is poorly tolerated. In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease
Keywords
COPD, NIV, Acute Hypercapnic Respiratory Failure, COPD patients with hypercapnic respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Helmet to deliver NIV
Arm Type
Experimental
Arm Title
Total Face to deliver NIV
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Helmet (Starmed)
Other Intervention Name(s)
Starmed Helmet
Intervention Description
The helmet is a kind of interface similar to a hood to deliver NIV
Intervention Type
Device
Intervention Name(s)
Total Face mask (Respironics)
Other Intervention Name(s)
Respironics Performax or similar
Intervention Description
The total face mask is the "classical" interface for NIV delivery
Primary Outcome Measure Information:
Title
Arterial Blood gases
Time Frame
at 1 hour after the start of NIV
Secondary Outcome Measure Information:
Title
Arterial Blood Gases
Time Frame
Once a day at 8 am until discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pH < 7,35 and PaCO2 > 45 mmHg respiratory rate > 20 b/min Exclusion Criteria: hypoxic respiratory failure coma inability to stand NIV lack of informed consent
Facility Information:
Facility Name
Sant'Orsola malpighi Hospital
City
Bologna
ZIP/Postal Code
40185
Country
Italy
Facility Name
Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40185
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25504992
Citation
Pisani L, Mega C, Vaschetto R, Bellone A, Scala R, Cosentini R, Musti M, Del Forno M, Grassi M, Fasano L, Navalesi P, Nava S. Oronasal mask versus helmet in acute hypercapnic respiratory failure. Eur Respir J. 2015 Mar;45(3):691-9. doi: 10.1183/09031936.00053814. Epub 2014 Dec 10.
Results Reference
derived

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Helmet Ventilation in Acute Hypercapnic Respiratory Failure

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