Helmet Ventilation in Acute Hypercapnic Respiratory Failure | NCT01645358

Studies
Helmet Ventilation in Acute Hypercapnic Respiratory Failure

NCT01645358

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Completed

Last Update Posted

Oct 7, 2014Estimated

Enrollment

80Actual

Phase

Phase 4

Conditions

Hypercapnic Respiratory Failure
Chronic Obstructive Pulmonary Disease

Interventions

Helmet (Starmed)
Total Face mask (Respironics)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Mar 22, 2012

First Submission Date that Met QC Criteria

Jul 18, 2012

First Posted Date

Jul 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2014

Last Update Posted Date

Oct 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

dr. Stefano Nava, Chief Respiratory and Critical care, IRCCS Azienda Ospedaliero-Universitaria di BolognaPrincipal Investigator

Lead Sponsor

IRCCS Azienda Ospedaliero-Universitaria di BolognaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Helmet to deliver NIV	Experimental		Device: Helmet (Starmed)
Total Face to deliver NIV	Active Comparator		Device: Total Face mask (Respironics)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Helmet (Starmed)	Device	The helmet is a kind of interface similar to a hood to deliver NIV	Helmet to deliver NIV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Arterial Blood gases		at 1 hour after the start of NIV

Secondary Outcomes

Measure	Description	Time Frame
Arterial Blood Gases		Once a day at 8 am until discharge

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sant'Orsola malpighi Hospital		Bologna		40185	Italy
Sant'Orsola Malpighi

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25504992	Derived	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.

ID	Term
D012131	Respiratory Insufficiency
D029424	Pulmonary Disease, Chronic Obstructive

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
D000067393	Personal Protective Equipment
D011482	Protective Devices
D004864	Equipment and Supplies
D008420	Manufactured Materials