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

NCT02578992 | Completed Results

• 1 other identifier: 2-103-05-125
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult

Keywords

intubating stylet; head and neck position

Outcome Measures

Primary Outcomes (1)

• Intubation Time

  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.

  from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts

Secondary Outcomes (3)

• Modified Cormack-Lehane Grade

  during intubation, after epiglottis was identified on the video monitor

• Mean Arterial Pressure

  before and after intubation, up to 5 minutes

• Visual Analog Scale of Sore Throat

  after anesthesia emergence 30 minutest, at post-anesthesia care unit

Study Arms (2)

Head-lift Position

EXPERIMENTAL

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; Device: 7cm high pillow

Neutral Position

NO INTERVENTION

The patients' head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique

Interventions

Head-lift position PROCEDURE

A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.

Head-lift Position

7cm high pillow DEVICE

A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.

Head-lift Position

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan, 114, Taiwan

Location

Limitations and Caveats

Tracheal intubation with Trachway was performed by an novice anesthesiologist.

Results Point of Contact

• Title: Dr. Wei-Hung Chan
• Organization: Tri-Service General Hospital

whcken@gmail.com

+886-2-87927128

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 19, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 9, 2016
• Results First Posted: December 9, 2016

Record last verified: 2016-10

Locations

TW (1)