Effect of Head Rotation on Efficiency of Face Mask Ventilation in Anesthetized Apneic Adults

NCT ID: NCT02755077

Last Updated: 2016-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Mask ventilation in rotated head position

Patient's head will be axially rotated 45 degrees to the right

Group Type EXPERIMENTAL

Head rotation during mask ventilation

Intervention Type PROCEDURE

Patient's head position is axially rotated 45 degrees to the right.

Mask ventilation in neutral head position

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Head rotation during mask ventilation

Patient's head position is axially rotated 45 degrees to the right.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeremi R Mountjoy

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremi R Mountjoy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

References

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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.

Reference Type BACKGROUND
PMID: 23364566 (View on PubMed)

Isono 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.

Reference Type BACKGROUND
PMID: 12357140 (View on PubMed)

Walsh 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.

Reference Type BACKGROUND
PMID: 18853942 (View on PubMed)

Itagaki 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.

Reference Type DERIVED
PMID: 28009638 (View on PubMed)

Other Identifiers

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2013P002571

Identifier Type: -

Identifier Source: org_study_id

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