Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope

This study has been completed.
Sponsor:
Information provided by:
NHS Grampian
ClinicalTrials.gov Identifier:
NCT00633867
First received: March 4, 2008
Last updated: July 29, 2011
Last verified: March 2008
Results First Received: February 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Tracheal Intubation
Interventions: Device: McGrath
Device: Tracheal intubation using Macintosh Laryngoscope

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
adult patients undergoing elective tracheal intubation at induction of anaesthesia Between February and August 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
139 patients consented for study. 120 assigned to groups. 19 not studied: no McGrath® scope available (n=10). No direct supervision of intubator (n=6). Case cancellation or changes (n=3).

Reporting Groups
  Description
McGrath Tracheal Intubation using McGrath video-laryngoscope
Macintosh Tracheal intubation using Macintosh Laryngoscope

Participant Flow:   Overall Study
    McGrath     Macintosh  
STARTED     60     60  
COMPLETED     60     60  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
McGrath Tracheal Intubation using McGrath video-laryngoscope
Macintosh Tracheal intubation using Macintosh Laryngoscope
Total Total of all reporting groups

Baseline Measures
    McGrath     Macintosh     Total  
Number of Participants  
[units: participants]
  60     60     120  
Age, Customized  
[units: Years]
Median ( Inter-Quartile Range )
  48  
  ( 39 to 63.5 )  
  60.5  
  ( 41.3 to 70 )  
  54  
  ( 40 to 66.5 )  
Gender  
[units: participants]
     
Female     43     41     84  
Male     17     19     36  
Region of Enrollment  
[units: participants]
     
United Kingdom     60     60     120  



  Outcome Measures

1.  Primary:   Intubation Time   [ Time Frame: At intubation ]

2.  Secondary:   Difference in Learning to Use the Scopes   [ Time Frame: At analysis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Quality of View of the Vocal Cords   [ Time Frame: At analysis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Number of Attempts to Secure Successful Intubation   [ Time Frame: At analysis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Incidence of Initial Oesophageal Intubation   [ Time Frame: At analysis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Number of Intubations Taking More Than 70 Seconds   [ Time Frame: At Analysis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Incidence of Low Arterial Saturation During Intubation   [ Time Frame: At analysis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Incidence of Visible Trauma to the Airway   [ Time Frame: At analysis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: W Brampton
Organization: NHS Grampian
e-mail: william.brampton@nhs.net


Publications of Results:

Responsible Party: Doctor William Brampton, NHS Grampian
ClinicalTrials.gov Identifier: NCT00633867     History of Changes
Other Study ID Numbers: 08-so802-4
Study First Received: March 4, 2008
Results First Received: February 25, 2010
Last Updated: July 29, 2011
Health Authority: United Kingdom: Research Ethics Committee