Acute Respiratory InsufficiencyNCT00686257
Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure
A study testing Total face mask (interface for NPPV) and Comfort full or RT040 oronasal mask (interface for NPPV) in people with Acute Respiratory Insufficiency, run by Tufts Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Insufficiency
- What is being tested?
- Total face mask (interface for NPPV) and Comfort full or RT040 oronasal mask (interface for NPPV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2003to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18
- Either A or B
- Clinical Criteria: Moderate to severe respiratory distress as evidenced by tachypnea, use of accessory muscles for breathing, or abdominal paradox.
- Blood Gas and Physiologic Criteria: Gas exchange abnormalities including PaCO2>45 with a pH<7.35, or a PaO2/FiO2 ratio<200.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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).
Read the detailed description
Despite its demonstrated efficacy in treating selected patients with acute respiratory failure, the application of NPPV is still plagued by a substantial failure rate, ranging from below 10% to above 40%. Mask intolerance ranks as one of the most common causes of failure. This is related to ill-fitting masks, mask discomfort (despite a properly fitted mask), excessively tightened straps, excessive air leaks around the mask or through the mouth, and claustrophobia.
The most commonly used masks in the acute care setting are either oronasal masks that cover the nose and mouth, or nasal masks that cover the nose alone. Both mask types usually consist of clear plastic dome-shaped mask with a soft silicon gasket to create an air seal with the skin. While this approach is usually successful, it may lead to patient discomfort and/or an air leak secondary to the difficulty in creating an effective seal over the bridge of the nose and over mobile structures such as the mandible. The Total Face Mask ™ (Respironics, Inc., Pittsburgh, PA) uses a different approach to avoid some of these limitations. Considerably larger than a standard oronasal mask, it covers the entire face and creates an air seal using a silicon gasket around the parameter of the face. In this way, gasket pressure is more evenly distributed, and discomfort over the bridge of the nose or chin is eliminated, and air leaking reduced. In addition, because one mask size fits virtually all patients, the Total Face Mask ™ facilitates the fitting process and permits more rapid initiation of ventilatory assistance. Clinical experience to date suggests that claustrophobia is not a common problem with the Total Face Mask ™ despite its size, and that its contribution to dead space is comparable to that of most oronasal masks.
The following protocol aims to compare use of the Total Face Mask ™ to the Comfort Full oronasal mask (also by Respironics, Inc., Pittsburgh, PA)or RT040 oronasal mask (Fisher\&Paykel Inc., Wellington, NZ) in the acute care setting for patients meeting standard indications for NPPV.
- Conditions
- Acute Respiratory Insufficiency
- Being tested
- Total face mask (interface for NPPV), Comfort full or RT040 oronasal mask (interface for NPPV)
- Keywords
- acute respiratory insufficiency, noninvasive ventilation, oronasal face mask, total face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total face mask (interface for NPPV)Device
Also called cephalic mask
NPPV is applied by this mask, as long as NPPV is received.
Comfort full or RT040 oronasal mask (interface for NPPV)Device
Also called Full face mask
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients receiving NPPV by the 'Total Face Mask' Receives: Device: Total face mask (interface for NPPV) |
| 2 | Active comparator | Patients receiving NPPV by 'standard oronasal mask' Receives: Device: Comfort full or RT040 oronasal mask (interface for NPPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)
Measured: During the first 3 hours of recruitment
Time Required for Mask Placement
Measured: at the initiation of NPPV
Secondary outcomes (6)
Early NIV Discontinuation Rate
Defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support
Measured: During hospitalization period (after recruitment into the study)
Deterioration Vital Signs
Measured: during the first 24 hours of the study
Deterioration in Gas Exchange
Measured: during the first 24 hours of the study
Total Length of Time Requiring NIV
Measured: during hospitalization (after recruitment)
Length of Hospital Stay
Measured: during hospitalization (after recruitment)
In-hospital Mortality Rate
Measured: during hospitalization (after recruitment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startJan 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital
- Responsible party
- Sponsor
- Investigators
- Aylin Ozsancak, MD, Study chair, Research FellowNicholas S. Hill, MD, Principal investigator, Chair of Pulmonary, Critical Care and Sleep DivisionSamy Sidhom, MD, MPH, Study director, Clinical Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686257
- Sponsor's protocol ID
- IRB-6060
- Status last verified
- May 2018
- First submitted
- 27 May 2008
- Last updated
- 25 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21330385
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT00686257
- Acronym / sponsor ID
- IRB-6060
- Conditions
- Acute Respiratory Insufficiency
- Keywords
- acute respiratory insufficiency, noninvasive ventilation, oronasal face mask, total face mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Rhode Island Hospital
- Study start
- Jan 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 May 2008 (estimated)
- Results
- Posted 27 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Despite its demonstrated efficacy in treating selected patients with acute respiratory failure, the application of NPPV is still plagued by a substantial failure rate, ranging from below 10% to above 40%. Mask intolerance ranks as one of the most common causes of failure. This is related to ill-fitting masks, mask discomfort (despite a properly fitted mask), excessively tightened straps, excessive air leaks around the mask or through the mouth, and claustrophobia.
The most commonly used masks in the acute care setting are either oronasal masks that cover the nose and mouth, or nasal masks that cover the nose alone. Both mask types usually consist of clear plastic dome-shaped mask with a soft silicon gasket to create an air seal with the skin. While this approach is usually successful, it may lead to patient discomfort and/or an air leak secondary to the difficulty in creating an effective seal over the bridge of the nose and over mobile structures such as the mandible. The Total Face Mask ™ (Respironics, Inc., Pittsburgh, PA) uses a different approach to avoid some of these limitations. Considerably larger than a standard oronasal mask, it covers the entire face and creates an air seal using a silicon gasket around the parameter of the face. In this way, gasket pressure is more evenly distributed, and discomfort over the bridge of the nose or chin is eliminated, and air leaking reduced. In addition, because one mask size fits virtually all patients, the Total Face Mask ™ facilitates the fitting process and permits more rapid initiation of ventilatory assistance. Clinical experience to date suggests that claustrophobia is not a common problem with the Total Face Mask ™ despite its size, and that its contribution to dead space is comparable to that of most oronasal masks.
The following protocol aims to compare use of the Total Face Mask ™ to the Comfort Full oronasal mask (also by Respironics, Inc., Pittsburgh, PA)or RT040 oronasal mask (Fisher\&Paykel Inc., Wellington, NZ) in the acute care setting for patients meeting standard indications for NPPV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Total face mask (interface for NPPV)Patients receiving NPPV by the 'Total Face Mask' |
| 2 | Active comparator | Device: Comfort full or RT040 oronasal mask (interface for NPPV)Patients receiving NPPV by 'standard oronasal mask' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>18
- Either A or B
- Clinical Criteria: Moderate to severe respiratory distress as evidenced by tachypnea, use of accessory muscles for breathing, or abdominal paradox.
- Blood Gas and Physiologic Criteria: Gas exchange abnormalities including PaCO2>45 with a pH<7.35, or a PaO2/FiO2 ratio<200.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total face mask (interface for NPPV)Also: cephalic maskNPPV is applied by this mask, as long as NPPV is received. | Device | 1 |
| Comfort full or RT040 oronasal mask (interface for NPPV)Also: Full face maskNPPV 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. | Device | 2 |
Primary outcome
Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)
Time frame: During the first 3 hours of recruitment
Time Required for Mask Placement
Time frame: at the initiation of NPPV
6 secondary outcomes
Early NIV Discontinuation Rate
Time frame: During hospitalization period (after recruitment into the study)
Deterioration Vital Signs
Time frame: during the first 24 hours of the study
Deterioration in Gas Exchange
Time frame: during the first 24 hours of the study
Total Length of Time Requiring NIV
Time frame: during hospitalization (after recruitment)
Length of Hospital Stay
Time frame: during hospitalization (after recruitment)
In-hospital Mortality Rate
Time frame: during hospitalization (after recruitment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21330385Ozsancak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aylin Ozsancak, MD study chair
Research Fellow
Nicholas S. Hill, MD principal investigator
Chair of Pulmonary, Critical Care and Sleep Division
Samy Sidhom, MD, MPH study director
Clinical Fellow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total face mask (interface for NPPV) and Comfort full or RT040 oronasal mask (interface for NPPV) in people with Acute Respiratory Insufficiency, run by Tufts Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) (time frame: During the first 3 hours of recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00686257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.