AnesthesiaNCT02755077
Effect of Head Rotation on Efficiency of Face Mask Ventilation in Anesthetized Apneic Adults
A study testing Head rotation during mask ventilation in people with Anesthesia, run by Massachusetts General Hospital.
Trial summary
Upper airway obstruction commonly occurs after induction of general anesthesia. The aim of this study is to determine if head rotation improves the efficiency of mask ventilation of anesthetized apneic adults. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Head rotation during mask ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jan 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with body mass index in the range of 18.5 to 35.0 kg/m2, who meet American society of anesthesiologists physical status classification I to III and require general anesthesia with tracheal intubation.
Who cannot join
- Patients with limited head rotation/extension, gastro-esophageal reflux or a full stomach, known sleep apnea in continuous positive airway pressure therapy and any anticipated difficult airway likely requiring awake intubation.
About this study
Official title: Effect of Head Rotation on Efficiency of Face Mask Ventilation in Anesthetized Apneic Adults: A Prospective Randomized Crossover Study
Upper airway obstruction commonly occurs after induction of general anesthesia. The aim of this study is to determine if head rotation improves the efficiency of mask ventilation of anesthetized apneic adults.
Read the detailed description
When apnea is achieved after induction, face mask ventilation is started in either a neutral head position or a head position axially rotated 45 degrees to the right. Mask ventilation will be carried out for 1 minute (Step 1) with pressure control ventilation of an anesthesia machine at peak inspiratory pressure 15 cmH2O, 10 breaths per minute, inspiration time to expiration time ratio 1:2 and no positive end-expiratory pressure. Then, mask ventilation will continue but head position will be crossed over (Step 2) and Step 1 will be repeated (Step 3). Expiratory tidal volume (VTE) will be measured by using respiratory inductive plethysmograph.
- Conditions
- Anesthesia
- Being tested
- Head rotation during mask ventilation
- Keywords
- Anesthesia induction, Airway, Mask ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head rotation during mask ventilationProcedure or surgery
Patient's head position is axially rotated 45 degrees to the right.
| Study group | Role | What they receive |
|---|---|---|
| Mask ventilation in rotated head position | Experimental | Patient's head will be axially rotated 45 degrees to the right Receives: Procedure: Head rotation during mask ventilation |
| Mask ventilation in neutral head position | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in averaged expiratory tidal volume measured by Respiratory monitor
Change in tidal volume between data of 2 min and average data from 1 and 3 min
Measured: 1, 2 and 3 min after the initiation of mask ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremi R Mountjoy, Massachusetts General Hospital
- Investigators
- Jeremi R Mountjoy, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755077
- Sponsor's protocol ID
- 2013P002571
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
PubMed 23364566Isono S, Tanaka A, Nishino T. Lateral position decreases collapsibility of the passive pharynx in patients with obstructive sleep apnea. Anesthesiology. 2002 Oct;97(4):780-5. doi: 10.1097/00000542-200210000-00006.
PubMed 12357140Walsh JH, Maddison KJ, Platt PR, Hillman DR, Eastwood PR. Influence of head extension, flexion, and rotation on collapsibility of the passive upper airway. Sleep. 2008 Oct;31(10):1440-7.
PubMed 18853942Itagaki T, Oto J, Burns SM, Jiang Y, Kacmarek RM, Mountjoy JR. The effect of head rotation on efficiency of face mask ventilation in anaesthetised apnoeic adults: A randomised, crossover study. Eur J Anaesthesiol. 2017 Jul;34(7):432-440. doi: 10.1097/EJA.0000000000000582.
PubMed 28009638
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Head Rotation on Efficiency of Face Mask Ventilation in Anesthetized Apneic Adults: A Prospective Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT02755077
- Acronym / sponsor ID
- 2013P002571
- Conditions
- Anesthesia
- Keywords
- Anesthesia induction, Airway, Mask ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Apr 2016 (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 commonly occurs after induction of general anesthesia. The aim of this study is to determine if head rotation improves the efficiency of mask ventilation of anesthetized apneic adults.
Detailed description
When apnea is achieved after induction, face mask ventilation is started in either a neutral head position or a head position axially rotated 45 degrees to the right. Mask ventilation will be carried out for 1 minute (Step 1) with pressure control ventilation of an anesthesia machine at peak inspiratory pressure 15 cmH2O, 10 breaths per minute, inspiration time to expiration time ratio 1:2 and no positive end-expiratory pressure. Then, mask ventilation will continue but head position will be crossed over (Step 2) and Step 1 will be repeated (Step 3). Expiratory tidal volume (VTE) will be measured by using respiratory inductive plethysmograph.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mask ventilation in rotated head position | Experimental | Procedure: Head rotation during mask ventilationPatient's head will be axially rotated 45 degrees to the right |
| Mask ventilation in neutral head position | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with body mass index in the range of 18.5 to 35.0 kg/m2, who meet American society of anesthesiologists physical status classification I to III and require general anesthesia with tracheal intubation.
Key exclusion criteria (1 listed)
- Patients with limited head rotation/extension, gastro-esophageal reflux or a full stomach, known sleep apnea in continuous positive airway pressure therapy and any anticipated difficult airway likely requiring awake intubation.
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 |
|---|---|---|
| Head rotation during mask ventilationPatient's head position is axially rotated 45 degrees to the right. | Procedure or surgery | Mask ventilation in rotated head position |
Primary outcome
Change in averaged expiratory tidal volume measured by Respiratory monitor
Time frame: 1, 2 and 3 min after the initiation of mask ventilation
Change in tidal volume between data of 2 min and average data from 1 and 3 min
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 28 Apr 2016.
- Background: PubMed 23364566Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
- Background: PubMed 12357140Isono S, Tanaka A, Nishino T. Lateral position decreases collapsibility of the passive pharynx in patients with obstructive sleep apnea. Anesthesiology. 2002 Oct;97(4):780-5. doi: 10.1097/00000542-200210000-00006.
- Background: PubMed 18853942Walsh JH, Maddison KJ, Platt PR, Hillman DR, Eastwood PR. Influence of head extension, flexion, and rotation on collapsibility of the passive upper airway. Sleep. 2008 Oct;31(10):1440-7.
- Derived from this study: PubMed 28009638Itagaki T, Oto J, Burns SM, Jiang Y, Kacmarek RM, Mountjoy JR. The effect of head rotation on efficiency of face mask ventilation in anaesthetised apnoeic adults: A randomised, crossover study. Eur J Anaesthesiol. 2017 Jul;34(7):432-440. doi: 10.1097/EJA.0000000000000582.
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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.
Jeremi R Mountjoy, M.D. principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Head rotation during mask ventilation in people with Anesthesia, run by Massachusetts General Hospital.
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 1 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in averaged expiratory tidal volume measured by Respiratory monitor (time frame: 1, 2 and 3 min after the initiation of mask ventilation). 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 NCT02755077, which also lists 4 linked publications.
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 28 Apr 2016.