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

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980590
• Other study ID #: 44-012
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: December 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intubation

Intervention

Device:
• Airway Scope
Tracheal intubation by Airway Scope
• Macintosh Laryngoscope
Tracheal intubation by Macintosh Laryngoscope

Locations

Country	Name	City	State
Japan	Kosei Hospital,.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation Time	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.	The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography.
Secondary	Overall Intubation Success Rate		Intubation period
Secondary	Number of Intubation Attempts		Intubation period
Secondary	Incidence of Intubation Complications	Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2<95%) and Esophageal intubation	Intubation period