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Laryngoscope Versus CMAC for Endotracheal Intubation in Patients Undergoing Emergent Airway Management

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ClinicalTrials.gov Identifier: NCT01710891
Recruitment Status : Completed
First Posted : October 19, 2012
Results First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Respiratory Distress
Interventions Procedure: CMAC videolaryngoscope
Procedure: Direct Laryngoscopy
Enrollment 198
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Direct Laryngoscopy CMAC
Hide Arm/Group Description

Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.

Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.

Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance

CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope

Period Title: Overall Study
Started 95 103
Completed 95 103
Not Completed 0 0
Arm/Group Title Direct Laryngoscopy CMAC Total
Hide Arm/Group Description

Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.

Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.

Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance

CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope

Total of all reporting groups
Overall Number of Baseline Participants 95 103 198
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 95 participants 103 participants 198 participants
51.6
(19 to 88)
52.6
(19 to 86)
52.1
(19 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 103 participants 198 participants
Female
32
  33.7%
41
  39.8%
73
  36.9%
Male
63
  66.3%
62
  60.2%
125
  63.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 95 participants 103 participants 198 participants
95 103 198
1.Primary Outcome
Title First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device.
Hide Description An attempt is counted as the intubating device entering the patients mouth until it is removed. Intubation success is defined as the endotracheal tube being placed in the patients lungs as confirmed by auscultation and end tidal carbon dioxide
Time Frame During intubation procedure up to 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy CMAC
Hide Arm/Group Description:

Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.

Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.

Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance

CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope

Overall Number of Participants Analyzed 95 103
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.3
(79.2 to 93.4)
92.2
(87.0 to 97.5)
2.Primary Outcome
Title Time to Intubation
Hide Description The time in seconds from the time at which the intubating device is first placed in the patient's mouth until the time of successful intubation
Time Frame From the time the first device entered the patients mouth until successful intubation up to 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy CMAC
Hide Arm/Group Description:

Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.

Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.

Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance

CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope

Overall Number of Participants Analyzed 95 103
Mean (95% Confidence Interval)
Unit of Measure: Seconds
58
(49 to 69)
61
(46 to 77)
3.Secondary Outcome
Title Length of Stay
Hide Description The time in days from hospital admission until discharge.
Time Frame From the time of hospital admission until discharge up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy CMAC
Hide Arm/Group Description:

Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.

Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.

Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance

CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope

Overall Number of Participants Analyzed 95 103
Median (95% Confidence Interval)
Unit of Measure: Days
9.1
(6.6 to 11.5)
8.5
(6.6 to 10.3)
4.Secondary Outcome
Title Aspiration Pneumonia
Hide Description The occurrence of aspiration pneumonia as defined by the clinical diagnosis in the patients chart and or radiographic determination of aspiration during the 28 days after the intubation procedure
Time Frame from the time of hospital admission up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy CMAC
Hide Arm/Group Description:

Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.

Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.

Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance

CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope

Overall Number of Participants Analyzed 90 96
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Aspiration Pneumonia
12.2
(5.3 to 19.1)
7.2
(2.0 to 12.6)
5.Secondary Outcome
Title Incidence of Hypoxia
Hide Description Oxygen saturations will be recorded during the procedure, oxygen saturation less than 93% will be considered an occurrence of hypoxia
Time Frame From the start of the procedure until successful intubation up to 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy CMAC
Hide Arm/Group Description:

Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.

Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.

Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance

CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope

Overall Number of Participants Analyzed 95 103
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Hypoxemia
27.3
(18.4 to 36.3)
25.2
(16.9 to 33.6)
6.Secondary Outcome
Title Failed Intubation
Hide Description Defined as the operator switching to an alternate device or intubation technique after at least one unsuccessful intubation attempt.
Time Frame from the start of the procedure until successful intubation up to one hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy CMAC
Hide Arm/Group Description:

Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.

Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.

Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance

CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope

Overall Number of Participants Analyzed 13 8
Measure Type: Number
Unit of Measure: percentage of participants
61.5 25
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Direct Laryngoscopy CMAC
Hide Arm/Group Description

Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.

Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.

Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance

CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope

All-Cause Mortality
Direct Laryngoscopy CMAC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Direct Laryngoscopy CMAC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/95 (0.00%)   0/103 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Direct Laryngoscopy CMAC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/95 (0.00%)   0/103 (0.00%) 
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.
Results Point of Contact
Name/Title: Brian Driver
Organization: MinneapolisMRF
Phone: 6128739528
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01710891     History of Changes
Other Study ID Numbers: HSR 11-3338
First Submitted: October 15, 2012
First Posted: October 19, 2012
Results First Submitted: February 18, 2016
Results First Posted: March 15, 2019
Last Update Posted: March 15, 2019