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Completed

NCT Number: NCT00980590

Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground

Pre-hospital intubation is often required in sub-optimal conditions, such as in patients lying on the ground. Direct laryngoscopy and intubation of a patient lying supine on the ground is difficult because the intubator's head is far above the head of the patient. It is thus tricky to align the intubator's visual axis with the patient's tracheal axis. The Airway Scope is a new laryngoscope designed to facilitate intubation without requiring alignment of the oral, pharyngeal, and tracheal axes. We thus tested the hypothesis that the intubation with the Airway Scope is faster than the Macintosh laryngoscope in subjects lying on the ground.

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Key information

Conditions

Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kosei Hospital,.

Tokyo, 164-8617, Japan

About this study

Adult surgical patients were enrolled. Following anesthesia induction and muscle relaxation, direct laryngoscopy was performed as usual and airway characteristics noted. Patients were randomly assigned to tracheal intubation by either the Airway Scope (n=50) or the Macintosh laryngoscope (n=50). Intubation was performed from a table positioned at the height as the operating table, thus simulating intubating on the ground. Overall intubation success rate, time required for intubation, the number of attempts required for successful intubation, and airway complications related to intubation were recorded.

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 tracheal intubation as part of anesthesia and designated as American Society of Anesthesiologists (ASA) physical status I, II, or III.

Exclusion criteria

  • Patients with an increased risk of pulmonary aspiration, cervical spine pathology, anticipated airway difficulties (i.e., Mallampati grade IV or thyromental distance <6 cm), and American Society of Anesthesiologists physical status >III.

Treatment and study plan

Airway Scope

Device

Tracheal intubation by Airway Scope

Macintosh laryngoscope

Device

Tracheal intubation by Macintosh Laryngoscope

Primary outcomes

  1. Intubation Time

    Time frame: The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography.

    For the case with number of intubation attempt no more than 3, intubation time was defined as the total time of individual intubation attempt. Otherwise, intubation was defined as a failure and excluded from the calculation of intubation time.

Secondary outcomes

  1. Overall Intubation Success Rate

    Time frame: Intubation period

  2. Number of Intubation Attempts

    Time frame: Intubation period

  3. Incidence of Intubation Complications

    Time frame: Intubation period

    Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2<95%) and Esophageal intubation

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 21, 2009
Registry last updated
Jun 29, 2023

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

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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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