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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Head rotation during mask ventilation

• Registration Number: NCT02755077
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study Start: 2014-07
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Study First Posted: 2016-04-28
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mask ventilation in rotated head position	Head rotation during mask ventilation	Patient's head will be axially rotated 45 degrees to the right

Primary Outcome Measures

Name	Time	Method
Change in averaged expiratory tidal volume measured by Respiratory monitor	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