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

NCT02755077 | Completed

• 1 other identifier: 2013P002571
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anesthesia

Keywords

Anesthesia induction; Airway; Mask ventilation

Outcome Measures

Primary Outcomes (1)

• 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

  1, 2 and 3 min after the initiation of mask ventilation

Study Arms (2)

Mask ventilation in rotated head position

EXPERIMENTAL

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

Procedure: Head rotation during mask ventilation

Mask ventilation in neutral head position

NO INTERVENTION

Interventions

Head rotation during mask ventilation PROCEDURE

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

Mask ventilation in rotated head position

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (4)

• 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.

  PMID: 23364566 BACKGROUND

• 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.

  PMID: 12357140 BACKGROUND

• 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.

  PMID: 18853942 BACKGROUND

• 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.

  PMID: 28009638 DERIVED

Study Officials

• Jeremi R Mountjoy, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 28, 2016
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 28, 2016

Record last verified: 2016-04