Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00814775
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients where this may be difficult.

Condition or Disease	Intervention/Treatment	Phase
Intubation	Device: Fastrach Laryngeal Mask; Device: CTrach Laryngeal Mask	N/A

Detailed Description

Participant will be randomly assigned to receive one of 2 conventional airway devices - the Fastrach Laryngeal Mask Airway or the CTrach Laryngeal Mask Airway. This study will compare the time required for successful intubation between the two devices.

Postoperative visit will be performed to assess the participant's clinical condition and to receive participant's feed back.

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Comparison Between the Fastrach and CTrach Laryngeal Mask Airway for Intubation of Patients With a Mallampati Score 3 or 4
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 Fastrach Laryngeal Mask Airway intubation	Device: Fastrach Laryngeal Mask; Intubation of difficult airway using Fastrach Laryngeal Mask
Active Comparator: Group 2 Intubation of difficult airway using CTrach Laryngeal Mask	Device: CTrach Laryngeal Mask; CTrach Laryngeal Mask intubation

Outcome Measures

Primary Outcome Measures

1. To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy [from start of intubation to successfully intubated]

2. To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy [60 seconds]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with an ASA score of 1-3.

2. Scheduled for elective surgical procedure

3. Age 18 and above

4. Patients with Mallampati airway classification scores III and IV

Exclusion Criteria:

1. Current pregnancy

2. Patients undergoing brain aneurysm clipping brain arteriovenous malformation surgery or vascular surgery procedures

3. Patients with obstructive sleep apnea or with a history of difficult ventilation

4. Mouth opening less than 3 cm.

5. Patients with indication for awake fiberoptic intubation or with a history of difficult intubation

6. Patients with cancer of the neck or the upper airway

7. Emergent surgery, patients requiring rapid sequence induction

8. Patients with severe gastroesophageal reflux

9. Patients with severe cardiac, pulmonary, hepatic or renal co-morbidities. 10. Patients unable to consent their participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Marco Maurtua, MD, The Cleveland Clinic
• Study Chair: Daniel I Sessler, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00814775
• Other Study ID Numbers: 08-358
• First Posted: Dec 25, 2008
• Last Update Posted: Oct 17, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by The Cleveland Clinic: Laryngeal mask; Difficult intubation

Study Results

Participant Flow

Arm/Group Title	Fastrach	CTrach
Arm/Group Description	Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask	Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation
Period Title: Overall Study
STARTED	23	20
COMPLETED	23	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Fastrach	CTrach	Total
Arm/Group Description	Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask	Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation	Total of all reporting groups
Overall Participants	23	20	43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (16)	59 (15)	59 (16)
Sex: Female, Male (Count of Participants)
Female	8 34.8%	9 45%	17 39.5%
Male	15 65.2%	11 55%	26 60.5%

Outcome Measures

1. Primary Outcome

Title	To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy
Time Frame	from start of intubation to successfully intubated

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fastrach	CTrach
Arm/Group Description	Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask	Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation
Measure Participants	23	20
Median (Inter-Quartile Range) [seconds]	41	40

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fastrach, CTrach
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.72
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 95%; 0.55 to 2.37
	Parameter Dispersion	Type: Value:
	Estimation Comments	CTrach vs. Fastrach

2. Primary Outcome

Title	To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy
Time Frame	60 seconds

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fastrach	CTrach
Arm/Group Description	Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask	Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation
Measure Participants	23	20
Median (Inter-Quartile Range) [seconds]	35	40

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fastrach, CTrach
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.38 to 1.54
	Parameter Dispersion	Type: Value:
	Estimation Comments	CTrach vs. Fastrach

Adverse Events

Arm/Group Title	Fastrach		CTrach
Arm/Group Description	Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask		Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation
All Cause Mortality
	Fastrach		CTrach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fastrach		CTrach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Fastrach		CTrach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.