"Neutral Head Position" and "Head-lift Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults

• ClinicalTrials.gov Identifier: NCT02578992
• Recruitment Status: Completed
• First Posted: October 19, 2015
• Results First Posted: December 9, 2016
• Last Update Posted: December 9, 2016
• Sponsor: Tri-Service General Hospital
• Information provided by (Responsible Party): Wei-Hung Chan, Tri-Service General Hospital

Study Description

Brief Summary:

The purpose of this study is to investigate two different patient's head and neck positions(neutral head position and head-lift position) for the effectiveness of orotracheal intubation with using the "Clarus Video System (Trachway®)" intubating stylet.

Condition or disease	Intervention/treatment	Phase
Intubation; Difficult	Procedure: Head-lift position; Device: 7cm high pillow	Not Applicable

Detailed Description:

The sniffing position has traditionally been considered the optimal head position for direct laryngoscopy, However, it may aggravate cervical spine injury. The Trachway® video stylet is an intubating device that may avoid cervical movement during intubation. Nonetheless, the effectiveness of limited neck movement in patients with neutral head or head-lift position using the Trachway® video stylet remains unclear. The purpose of this study was to compare the intubation time of the two positions with the Trachway® video stylet.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: "Neutral Head Position" and "Head-lift Position" for Orotrachwal Intubation With "Trachway" Intubating Stylet in Adults
• Study Start Date: December 2014
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Head-lift Position; The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique	Procedure: Head-lift position; A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.; Device: 7cm high pillow; A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.
No Intervention: Neutral Position; The patients' head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique

Outcome Measures

Primary Outcome Measures :

1. Intubation Time [ Time Frame: from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts ]
   the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch.

Secondary Outcome Measures :

1. Modified Cormack-Lehane Grade [ Time Frame: during intubation, after epiglottis was identified on the video monitor ]

   The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.

   Scale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome.

2. Mean Arterial Pressure [ Time Frame: before and after intubation, up to 5 minutes ]
   compare the mean arterial pressure between two groups.
3. Visual Analog Scale of Sore Throat [ Time Frame: after anesthesia emergence 30 minutest, at post-anesthesia care unit ]

   All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit.

   Scale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• patients scheduled for various surgeries requiring general anesthesia with tracheal intubation
• American Society of Anesthesiologists(ASA) physical status classification I-III

Exclusion Criteria:

• pneumothorax
• room air saturation by pulse oximeter saturation less than 96%
• vocal cord palsy
• craniofacial anomaly
• congenital upper airway anomaly
• upper airway disease
• cervical spine pathology
• head and neck tumor status post radiotherapy
• an increased risk of regurgitation or pulmonary aspiration
• a history of difficult tracheal intubation

Contacts and Locations

Locations

Taiwan

Tri-Service General Hospital

Taipei, Taiwan, 114

Sponsors and Collaborators

Tri-Service General Hospital

More Information

• Responsible Party: Wei-Hung Chan, Dr., Tri-Service General Hospital
• ClinicalTrials.gov Identifier: NCT02578992
• Other Study ID Numbers: 2-103-05-125
• First Posted: October 19, 2015
• Results First Posted: December 9, 2016
• Last Update Posted: December 9, 2016
• Last Verified: October 2016

Keywords provided by Wei-Hung Chan, Tri-Service General Hospital:

intubating stylet; head and neck position