Upper Airway ObstructionNCT01524614
Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask
A study testing nasal mask in people with Upper Airway Obstruction, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Upper airway obstruction (UAO) is common complication during induction of general anesthesia. The mechanism of UAO during anesthesia has not been well understood. Posterior displacement of soft palate are believed to be the primary contributing factors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Airway Obstruction
- What is being tested?
- nasal mask
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients,between 18-65 years of age meeting ASA physical status classification I-II requiring general anesthesia for elective surgery who are able to breathe through both their nose and mouth while awake.
Who cannot join
- Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class III or greater.
- Abnormal vital signs on the day of admission for surgery [heart rate (HR, > 100 bpm or < 40 bpm), blood pressure (BP, > 180/100 mmHg or < 90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) < 96%] that are not correctable with his or her routine medication or commonly used pre-operative medication.
- Unable to open mouth (< 2.5 cm) or unable to breathe through their mouth or nose.
- Subjects with a beard, an abnormal facial structure or other factors precluding obtaining a viable face mask fit without air leak. Also, subjects having claustrophobia that can not tolerate the mask.
- Any person with an anticipated difficult airway. This will include subjects who require or may require either a fiberoptic intubation or intubation while awake and subjects with known OSA or body mass index (BMI) greater than 35 km/m2.
- Gastric-esophageal reflex or a full stomach.
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- The subject has remained in bed for more than 24 hours.
- Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or transient ischemic attack (TIA) within 2 weeks.
- Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative.
- Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os) guidelines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anesthesia and Critical Care, Mass General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effect of Continuous Positive Airway Pressure Ventilation Through Nasal Mask on Upper Airway Patency During Induction of Anesthesia
Upper airway obstruction (UAO) is common complication during induction of general anesthesia. The mechanism of UAO during anesthesia has not been well understood. Posterior displacement of soft palate are believed to be the primary contributing factors. The mechanism of UAO during anesthesia share many similarities with obstructive sleep apnea (OSA). Since nasal continuous positive airway pressure (nCPAP) can maintain the airway patent in patients with OSA, the investigators hypothesize that nCPAP during induction of anesthesia will reduce the incidence and severity of UAO.
- Conditions
- Upper Airway Obstruction
- Being tested
- nasal mask
- Keywords
- continuous positive airway pressure, nasal mask, upper airway obstruction
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal maskProcedure or surgery
nasal mask use instead of face mask
| Study group | Role | What they receive |
|---|---|---|
| Nasal mask with no PEEP | Experimental | Nasal mask with PEEP 0, then add PEEP 5, and 10 Receives: Procedure: nasal mask |
| Nasal mask with PEEP | Experimental | Nasal mask with PEEP 5, then add PEEP 10 Receives: Procedure: nasal mask |
| Face mask with no PEEP | Experimental | Face mask with PEEP 0 then add PEEP 5, 10 Receives: Procedure: nasal mask |
| Face mask with PEEP | Experimental | Face mask with PEEP 5, then add PEEP 10 Receives: Procedure: nasal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
expired tidal volume
Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.
Measured: Average of one minute after anesthesia induction
Secondary outcomes (1)
volume of CO2
Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.
Measured: Average of one minute after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Airway ObstructionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yandong Jiang, Massachusetts General Hospital
- Investigators
- Yandong Jiang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524614
- Sponsor's protocol ID
- 2010p002823
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2012
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oto J, Li Q, Kimball WR, Wang J, Sabouri AS, Harrell PG, Kacmarek RM, Jiang Y. Continuous positive airway pressure and ventilation are more effective with a nasal mask than a full face mask in unconscious subjects: a randomized controlled trial. Crit Care. 2013 Dec 23;17(6):R300. doi: 10.1186/cc13169.
PubMed 24365207
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure Ventilation Through Nasal Mask on Upper Airway Patency During Induction of Anesthesia
- ClinicalTrials.gov ID
- NCT01524614
- Acronym / sponsor ID
- 2010p002823
- Conditions
- Upper Airway Obstruction
- Keywords
- continuous positive airway pressure, nasal mask, upper airway obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Upper airway obstruction (UAO) is common complication during induction of general anesthesia. The mechanism of UAO during anesthesia has not been well understood. Posterior displacement of soft palate are believed to be the primary contributing factors. The mechanism of UAO during anesthesia share many similarities with obstructive sleep apnea (OSA). Since nasal continuous positive airway pressure (nCPAP) can maintain the airway patent in patients with OSA, the investigators hypothesize that nCPAP during induction of anesthesia will reduce the incidence and severity of UAO.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nasal mask with no PEEP | Experimental | Procedure: nasal maskNasal mask with PEEP 0, then add PEEP 5, and 10 |
| Nasal mask with PEEP | Experimental | Procedure: nasal maskNasal mask with PEEP 5, then add PEEP 10 |
| Face mask with no PEEP | Experimental | Procedure: nasal maskFace mask with PEEP 0 then add PEEP 5, 10 |
| Face mask with PEEP | Experimental | Procedure: nasal maskFace mask with PEEP 5, then add PEEP 10 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients,between 18-65 years of age meeting ASA physical status classification I-II requiring general anesthesia for elective surgery who are able to breathe through both their nose and mouth while awake.
Key exclusion criteria (10 listed)
- Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class III or greater.
- Abnormal vital signs on the day of admission for surgery [heart rate (HR, > 100 bpm or < 40 bpm), blood pressure (BP, > 180/100 mmHg or < 90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) < 96%] that are not correctable with his or her routine medication or commonly used pre-operative medication.
- Unable to open mouth (< 2.5 cm) or unable to breathe through their mouth or nose.
- Subjects with a beard, an abnormal facial structure or other factors precluding obtaining a viable face mask fit without air leak. Also, subjects having claustrophobia that can not tolerate the mask.
- Any person with an anticipated difficult airway. This will include subjects who require or may require either a fiberoptic intubation or intubation while awake and subjects with known OSA or body mass index (BMI) greater than 35 km/m2.
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 |
|---|---|---|
| nasal masknasal mask use instead of face mask | Procedure or surgery | Face mask with PEEP, Face mask with no PEEP, Nasal mask with PEEP, Nasal mask with no PEEP |
Primary outcome
expired tidal volume
Time frame: Average of one minute after anesthesia induction
Estimated time from induction of anesthesia (drugs given for anesthesia induction) to apnea is one minute.
1 secondary outcome
volume of CO2
Time frame: Average of one minute after anesthesia induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Derived from this study: PubMed 24365207Oto J, Li Q, Kimball WR, Wang J, Sabouri AS, Harrell PG, Kacmarek RM, Jiang Y. Continuous positive airway pressure and ventilation are more effective with a nasal mask than a full face mask in unconscious subjects: a randomized controlled trial. Crit Care. 2013 Dec 23;17(6):R300. doi: 10.1186/cc13169.
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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.
Yandong Jiang, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal mask in people with Upper Airway Obstruction, run by Massachusetts General Hospital at 1 site 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 1 inclusion and 10 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
expired tidal volume (time frame: Average of one minute after anesthesia induction). 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 NCT01524614, 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 18 Jan 2017.