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

This study has been completed.

Study NCT00633867 Information provided by NHS Grampian

First Received on March 4, 2008. Last Updated on July 29, 2011 History of Changes

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

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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

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Reporting Groups

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

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 ]

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2. Secondary:

Difference in Learning to Use the Scopes [ Time Frame: At analysis ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Quality of View of the Vocal Cords [ Time Frame: At analysis ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Number of Attempts to Secure Successful Intubation [ Time Frame: At analysis ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Incidence of Initial Oesophageal Intubation [ Time Frame: At analysis ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

6. Secondary:

Number of Intubations Taking More Than 70 Seconds [ Time Frame: At Analysis ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

7. Secondary:

Incidence of Low Arterial Saturation During Intubation [ Time Frame: At analysis ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

8. Secondary:

Incidence of Visible Trauma to the Airway [ Time Frame: At analysis ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
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Results Point of Contact:

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

Publications of Results:

Walker L, Brampton W, Halai M, Hoy C, Lee E, Scott I, McLernon DJ. Randomized controlled trial of intubation with the McGrath Series 5 videolaryngoscope by inexperienced anaesthetists. Br J Anaesth. 2009 Sep;103(3):440-5. Epub 2009 Jul 15.

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