NCT00686257

Brief Summary

The purpose of this study is to compare the Total Face Mask™ (Respironics, Inc., Pittsburgh, PA) (covering whole face) and the standard oronasal facemask (covering nose and mouth) for the emergency treatment of patients with acute respiratory failure with the machine blowing air into the mask placed on the face (noninvasive positive pressure ventilation) (NPPV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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, 2003

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

August 27, 2012

Completed
Last Updated

June 25, 2018

Status Verified

May 1, 2018

Enrollment Period

5.4 years

First QC Date

May 27, 2008

Results QC Date

May 30, 2012

Last Update Submit

May 25, 2018

Conditions

Acute Respiratory Insufficiency

Keywords

acute respiratory insufficiencynoninvasive ventilationoronasal face masktotal face mask

Outcome Measures

Primary Outcomes (2)

  • Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)

    During the first 3 hours of recruitment

  • Time Required for Mask Placement

    at the initiation of NPPV

Secondary Outcomes (6)

  • Early NIV Discontinuation Rate

    During hospitalization period (after recruitment into the study)

  • Deterioration Vital Signs

    during the first 24 hours of the study

  • Deterioration in Gas Exchange

    during the first 24 hours of the study

  • Total Length of Time Requiring NIV

    during hospitalization (after recruitment)

  • Length of Hospital Stay

    during hospitalization (after recruitment)

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Patients receiving NPPV by the 'Total Face Mask'

Device: Total face mask (interface for NPPV)

2

ACTIVE COMPARATOR

Patients receiving NPPV by 'standard oronasal mask'

Device: Comfort full or RT040 oronasal mask (interface for NPPV)

Interventions

Total face mask (interface for NPPV)DEVICE

NPPV is applied by this mask, as long as NPPV is received.

Also known as: cephalic mask
1
Comfort full or RT040 oronasal mask (interface for NPPV)DEVICE

NPPV is applied by one of these masks (Comfort full or RT040 masks used at Rhode Island Hospital and Tufts Medical Center respectively), as long as NPPV is received.

Also known as: Full face mask
2

Eligibility Criteria

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

You may qualify if:

  • Age\>18
  • Either A or B
  • A. Clinical Criteria: Moderate to severe respiratory distress as evidenced by tachypnea, use of accessory muscles for breathing, or abdominal paradox.
  • B. Blood Gas and Physiologic Criteria: Gas exchange abnormalities including PaCO2\>45 with a pH\<7.35, or a PaO2/FiO2 ratio\<200.

You may not qualify if:

  • The need for immediate intubation
  • Medical instability such as hypotensive shock, uncontrolled cardiac ischemia or arrythmias, unstable myocardial infarction, uncontrolled upper gastrointestinal bleeding
  • Agitation or uncooperativeness, unresponsive to small doses of sedatives
  • Excretions or inability to protect the airway
  • Inability to fit the mask
  • Facial trauma
  • Upper airway obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Ozsancak A, Sidhom SS, Liesching TN, Howard W, Hill NS. Evaluation of the total face mask for noninvasive ventilation to treat acute respiratory failure. Chest. 2011 May;139(5):1034-1041. doi: 10.1378/chest.10-1905. Epub 2011 Feb 17.

    PMID: 21330385RESULT

Limitations and Caveats

Could not blind subjects or investigators

Results Point of Contact

Title
Nicholas Hill MD
Organization
Tufts Medical Center
nhill@tuftsmedicalcenter.org
617-636-4288

Study Officials

  • Aylin Ozsancak, MD

    Research Fellow

    STUDY CHAIR

  • Nicholas S. Hill, MD

    Chair of Pulmonary, Critical Care and Sleep Division

    PRINCIPAL INVESTIGATOR

  • Samy Sidhom, MD, MPH

    Clinical Fellow

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 29, 2008

Study Start

January 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 25, 2018

Results First Posted

August 27, 2012

Record last verified: 2018-05

Locations

US(2)