Mechanical Ventilation ComplicationNCT01651286
Nasal Mask Ventilation During the Induction of General Anesthesia
A study testing nasal mask and full face mask in people with Mechanical Ventilation Complication and Upper Airway Obstruction, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Recently, the investigators demonstrated that nasal route ventilation is superior to the nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask ventilation during the induction of general… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Ventilation Complication, Upper Airway Obstruction
- What is being tested?
- nasal mask and full face mask
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2013
- 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
- 18-65 years of age
- ASA physical status classification I-II
- general anesthesia
- 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.
- Any person with an anticipated difficult airway. This will include subjects that require or may require either a fiberoptic intubation or intubation while awake.
- Gastric-esophageal reflex or a full stomach.
- 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 - Nothing By Mouth) guidelines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Determination of the Efficacy of Nasal Mask Ventilation During the Induction of General Anesthesia
Recently, the investigators demonstrated that nasal route ventilation is superior to the nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask ventilation during the induction of general anesthesia by: 1) producing a better seal than full face mask, and 2)establishing a greater airway patency and more effectively ventilate than full face mask ventilation. The investigators intend to test this hypothesis on adult patients during the induction of general anesthesia in the absence of muscle relaxation.
- Being tested
- nasal mask, full face mask
- Keywords
- General anesthesia, Positive-pressure ventilation, Masks
- 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
Using the nasal mask instead of the full face mask during the induction of general anesthesia
full face maskProcedure or surgery
using a standard full face mask during the induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| nasal mask | Experimental | when the patient is apneic after the injection of anesthetics in the operating room, a nasal mask will be applied with positive pressure ventilation for 1 min. Then the nasal mask will be replaced with a full face mask for 1 min. Subsequently, the face mask will be replaced with the nasal mask. Receives: Procedure: nasal mask; Procedure: full face mask |
| full face mask | Active comparator | when the patient is apneic after the injection of anesthetics in the operating room, a full face mask will be applied with positive pressure ventilation for 1 min. Then the full face mask will be replaced with a nasal mask for 1 min. Subsequently, the nasal mask will be replaced with the full face mask. Receives: Procedure: nasal mask; Procedure: full face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
Tidal volume generated by the positive pressure ventilation during the induction of general anesthesia
Measured: in 30 minutes after the induction of general anesthesia
Secondary outcomes (2)
Carbon dioxide removal
carbon dioxide removed per minute during the induction of general anesthesia will be calculated
Measured: in 30 minutes after the induction of general anesthesia
success rate of positive pressure ventilation with different masks
Measured: in 30 minute after the induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 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
- Hovig V Chitilian, MD, Principal investigator, Massachusetts General HospitalYandong Jiang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651286
- Sponsor's protocol ID
- 2011P001283
- Status last verified
- Jan 2017
- First submitted
- 6 Jun 2012
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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
- Determination of the Efficacy of Nasal Mask Ventilation During the Induction of General Anesthesia
- ClinicalTrials.gov ID
- NCT01651286
- Acronym / sponsor ID
- 2011P001283
- Keywords
- General anesthesia, Positive-pressure ventilation, Masks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 27 Jul 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.
Recently, the investigators demonstrated that nasal route ventilation is superior to the nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask ventilation during the induction of general anesthesia by: 1) producing a better seal than full face mask, and 2)establishing a greater airway patency and more effectively ventilate than full face mask ventilation. The investigators intend to test this hypothesis on adult patients during the induction of general anesthesia in the absence of muscle relaxation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal mask | Experimental | Procedure: nasal mask, Procedure: full face maskwhen the patient is apneic after the injection of anesthetics in the operating room, a nasal mask will be applied with positive pressure ventilation for 1 min. Then the nasal mask will be replaced with a full face mask for 1 min. Subsequently, the face mask will be replaced with the nasal mask. |
| full face mask | Active comparator | Procedure: nasal mask, Procedure: full face maskwhen the patient is apneic after the injection of anesthetics in the operating room, a full face mask will be applied with positive pressure ventilation for 1 min. Then the full face mask will be replaced with a nasal mask for 1 min. Subsequently, the nasal mask will be replaced with the full face mask. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years of age
- ASA physical status classification I-II
- general anesthesia
- elective surgery
- who are able to breathe through both their nose and mouth while awake
Key exclusion criteria (8 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.
- Any person with an anticipated difficult airway. This will include subjects that require or may require either a fiberoptic intubation or intubation while awake.
- Gastric-esophageal reflex or a full stomach.
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 maskUsing the nasal mask instead of the full face mask during the induction of general anesthesia | Procedure or surgery | full face mask, nasal mask |
| full face maskusing a standard full face mask during the induction of general anesthesia. | Procedure or surgery | full face mask, nasal mask |
Primary outcome
Tidal volume
Time frame: in 30 minutes after the induction of general anesthesia
Tidal volume generated by the positive pressure ventilation during the induction of general anesthesia
2 secondary outcomes
Carbon dioxide removal
Time frame: in 30 minutes after the induction of general anesthesia
success rate of positive pressure ventilation with different masks
Time frame: in 30 minute after the induction of general anesthesia
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.
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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.
Hovig V Chitilian, MD principal investigator
Massachusetts General Hospital
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 and full face mask in people with Mechanical Ventilation Complication and 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 5 inclusion and 8 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?
Tidal volume (time frame: in 30 minutes after the induction of general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.