Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway

• Sponsor: IWK Health Centre (Other)
• Overall Status: Completed
• CT.gov ID: NCT01491984
• Collaborator: (none)
• Enrollment: 105
• Arms: 2
• Duration (Months): 12

Study Details

Study Description

Brief Summary

A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation.

Condition or Disease	Intervention/Treatment	Phase
Airway Complication of Anaesthesia	Device: Laryngoscopy order: 1) MAC, 2) Levitan; Device: Laryngoscopy order: 1) Levitan, 2) MAC	Phase 4

Detailed Description

A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation. The placement of a breathing tube into the windpipe is a skill that is not easily mastered. In fact, the placement is difficult or impossible using the usual technique in 1-3 of every 100 patients. The ease of placing this breathing tube depends in part on how easily and how much of the vocal cords are able to be seen directly using a laryngoscope.

In a small number of patients, the Levitan First Pass Success (FPS) Scope has been shown to be more effective and easier to insert even in patients who have difficult airways. This study will evaluate the use of the LFS compared to the other conventional laryngoscope in subjects with a simulated difficult airway. The goal of this study is to determine the effectiveness and safety of the LFS in a large number of patients with simulated airway difficulties.

The results obtained during the study may provide useful information to health care providers who cannot place a breathing tube in patients that are either in operating rooms or in emergency situations requiring intubation by paramedics. An example would be a trauma situation where a paramedic is having difficulty attempting an intubation when a patients c-spine is being protected from any movements.

The LFS is an affordable and transportable device, which makes this an attractive asset for health providers in smaller community settings or in paramedic vehicles which may not have the capacity to stock or ability to afford a variety of different scopes and must choose a more limited selection.

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effectiveness and Safety of the Levitan FPS Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway in Surgical Subjects Under General Anesthesia
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laryngoscopy order: 1) MAC, 2) Levitan Levitan FPS Intubation	Device: Laryngoscopy order: 1) MAC, 2) Levitan; Laryngoscopy with MAC, then Levitan; Device: Laryngoscopy order: 1) Levitan, 2) MAC; Laryngoscopy with Levitan, then MAC
Experimental: Laryngoscopy order: 1) Levitan, 2) MAC Macintosh Intubation	Device: Laryngoscopy order: 1) MAC, 2) Levitan; Laryngoscopy with MAC, then Levitan; Device: Laryngoscopy order: 1) Levitan, 2) MAC; Laryngoscopy with Levitan, then MAC

Outcome Measures

Primary Outcome Measures

1. Cormack-Lehane Grade [intraoperative]

   The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale. Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen

Secondary Outcome Measures

1. Number of Intubation Attempts [intraoperative]

   Number of intubation attempts was recorded after intubation was completed.

2. Operator Rating of Difficulty [intraoperative]

   The attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale.

3. Time to Successful Intubation [intraoperative]

   Time to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I or II (healthy or mild systemic disease, ex. asthma, high blood pressure)

2. Elective surgery requiring endotracheal intubation

3. English speaking

4. Age 16 - 75 years

Exclusion Criteria:

1. Significant gastroesophageal reflux disease (GERD) that may require alternate induction/intubation techniques

2. Prior history of a difficult intubation requiring an awake tracheal intubation

3. Clinical predictors of a potentially difficult intubation requiring an awake intubation

4. BMI > 45 kg/m2 (Obesity is a common and important risk factor for difficult intubation)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• IWK Health Centre

Investigators

• Principal Investigator: Ronald B George, MD, IWK Health Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ronald George, Primary Investigator, MD, FRCPC, Assistant Professor, IWK Health Centre
• ClinicalTrials.gov Identifier: NCT01491984
• Other Study ID Numbers: IWK-4668-2009; IWK REB 4668
• First Posted: Dec 14, 2011
• Last Update Posted: Mar 10, 2015
• Last Verified: Feb 1, 2015

Study Results

Participant Flow

Recruitment Details	From July 29,2009 to March 12, 2010 we recruited women aged 16-75 yrs old, ASA class I-II, and undergoing elective gynecologic surgery at the IWK Health Centre under general anesthesia with planned orotracheal intubation.
Pre-assignment Detail	105 participants were consented and randomized, and of those 11 were withdrawn for either anticipated difficult airway, decreased SpO2, or unavailable staff/equipment. A total of 94 participants started the study protocol. 3 were withdrawn. 91 participants completed the study protocol.

Arm/Group Title	Levitan FPS/Mac Laryngoscope Intubation Order	Macintosh/Levitan FPS Laryngoscope Intubation Order
Arm/Group Description	Intubation with Levitan laryngoscopy view with Levitan :	traditional MAC intubation laryngoscopy view with MAC :
Period Title: Overall Study
STARTED	49	45
COMPLETED	47	44
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Intubation Order Levitan/MAC	Intubation Order MAC/Levitan	Total
Arm/Group Description	The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.	A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice).	Total of all reporting groups
Overall Participants	49	45	94
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (13)	45 (13)	45 (13)
Sex: Female, Male (Count of Participants)
Female	49 100%	45 100%	94 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Cormack-Lehane Grade
Description	The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale. Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen
Time Frame	intraoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levitan/MAC Intubation	MAC/Levitan Intubation
Arm/Group Description	Laryngoscopy with Levitan, then MAC	Laryngoscopy with MAC then Levitan
Measure Participants	91	94
Good Laryngoscopic View-Cormack-Lehane grade 1 & 2	58 118.4%	53 117.8%
Poor Laryngoscopic View-Cormack-Lehane grade 3 & 4	33 67.3%	41 91.1%

2. Secondary Outcome

Title	Number of Intubation Attempts
Description	Number of intubation attempts was recorded after intubation was completed.
Time Frame	intraoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Operator Rating of Difficulty
Description	The attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale.
Time Frame	intraoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Time to Successful Intubation
Description	Time to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal.
Time Frame	intraoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Levitan FPS Intubation		Macintosh Intubation
Arm/Group Description	The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.		A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice)
All Cause Mortality
	Levitan FPS Intubation		Macintosh Intubation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Levitan FPS Intubation		Macintosh Intubation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/91 (0%)		0/94 (0%)
Other (Not Including Serious) Adverse Events
	Levitan FPS Intubation		Macintosh Intubation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/91 (0%)		0/94 (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.