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Completed

NCT Number: NCT02578992

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

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.

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Key information

Conditions

Intubation; Difficult

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, Taiwan, 114

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Head-lift position

Procedure

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

7cm high pillow

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 19, 2015
Registry last updated
Dec 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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