Trial Outcomes & Findings for Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground (NCT NCT00980590)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

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

Results posted on

2023-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Airway Scope Intubation with Airway Scope Airway Scope: Tracheal intubation by Airway Scope	Macintosh Laryngoscope Intubation with Macintosh laryngoscope Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Airway Scope n=50 Participants Intubation with Airway Scope Airway Scope: Tracheal intubation by Airway Scope	Macintosh Laryngoscope n=50 Participants Intubation with Macintosh laryngoscope Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope	Total n=100 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 19 • n=5 Participants	53 years STANDARD_DEVIATION 18 • n=7 Participants	55 years STANDARD_DEVIATION 20 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	22 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants
Mouth opening	4.6 cm STANDARD_DEVIATION 0.7 • n=5 Participants	4.7 cm STANDARD_DEVIATION 0.7 • n=7 Participants	4.7 cm STANDARD_DEVIATION 0.7 • n=5 Participants
Height	158 cm STANDARD_DEVIATION 9 • n=5 Participants	162 cm STANDARD_DEVIATION 9 • n=7 Participants	160 cm STANDARD_DEVIATION 10 • n=5 Participants
Weight	56 kg STANDARD_DEVIATION 10 • n=5 Participants	58 kg STANDARD_DEVIATION 10 • n=7 Participants	57 kg STANDARD_DEVIATION 10 • n=5 Participants

PRIMARY outcome

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

Population: Patients with number of intubation attempt no more than 3

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.

Outcome measures

Outcome measures
Measure	Airway Scope n=49 Participants Intubation with Airway Scope Airway Scope: Tracheal intubation by Airway Scope	Macintosh Laryngoscope n=50 Participants Intubation with Macintosh laryngoscope Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope
Intubation Time	18 seconds Standard Deviation 4	35 seconds Standard Deviation 16

SECONDARY outcome

Timeframe: Intubation period

Outcome measures

Outcome measures
Measure	Airway Scope n=50 Participants Intubation with Airway Scope Airway Scope: Tracheal intubation by Airway Scope	Macintosh Laryngoscope n=50 Participants Intubation with Macintosh laryngoscope Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope
Overall Intubation Success Rate	98 Percentage of overall intubation	100 Percentage of overall intubation

SECONDARY outcome

Timeframe: Intubation period

Outcome measures

Outcome measures
Measure	Airway Scope n=50 Participants Intubation with Airway Scope Airway Scope: Tracheal intubation by Airway Scope	Macintosh Laryngoscope n=50 Participants Intubation with Macintosh laryngoscope Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope
Number of Intubation Attempts 1	37 times	45 times
Number of Intubation Attempts 2	10 times	5 times
Number of Intubation Attempts 3	3 times	0 times

SECONDARY outcome

Timeframe: Intubation period

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

Outcome measures

Outcome measures
Measure	Airway Scope n=50 Participants Intubation with Airway Scope Airway Scope: Tracheal intubation by Airway Scope	Macintosh Laryngoscope n=50 Participants Intubation with Macintosh laryngoscope Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope
Incidence of Intubation Complications Muscosal trauma	2 cases	5 cases
Incidence of Intubation Complications Dental injury	0 cases	1 cases
Incidence of Intubation Complications Lip injury	4 cases	6 cases
Incidence of Intubation Complications Hypoxia	0 cases	0 cases
Incidence of Intubation Complications Esophageal intubation	0 cases	1 cases

Adverse Events

Airway Scope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Macintosh Laryngoscope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Sessler

Cleveland Clinic

Phone: 216-445-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place