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Videolaryngoscopy in Patients With Cervical Spine Immobilisation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563301
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Lynsey Foulds, NHS Tayside

Tracking Information
First Submitted Date  ICMJE September 25, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date September 30, 2015
Study Start Date  ICMJE August 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
Cormack and Lehane laryngoscopy grade [ Time Frame: 5 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • Time to intubation [ Time Frame: 5 minutes ]
  • Rate of successful tracheal intubation [ Time Frame: 5 minutes ]
  • Incidence of complications [ Time Frame: 5 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Videolaryngoscopy in Patients With Cervical Spine Immobilisation
Official Title  ICMJE A Randomised Crossover Trial Comparing the McGrath Series 5 Videolaryngoscope With the Macintosh Laryngoscope in Patients With Cervical Spine Immobilisation
Brief Summary

Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a potential solution. The relatively short radius of the blade curvature combined with the internal arrangement of optimal components means that the glottis can be seen without the need for alignment of the oral, pharyngeal and tracheal axes.

The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view of the larynx in patients with limited neck movements, making intubation quicker, easier and possibly safer.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Intubation; Difficult
Intervention  ICMJE Device: Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is intubated.
Study Arms  ICMJE
  • Active Comparator: McGrath Series 5
    Videolaryngoscope used to perform indirect (video) laryngoscopy and tracheal intubation
    Intervention: Device: Laryngoscopy
  • Active Comparator: Macintosh
    Laryngoscope used to perform direct laryngoscopy and tracheal intubation
    Intervention: Device: Laryngoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2015)
49
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Elective procedure requiring tracheal intubation
  • Over 16 years of age

Exclusion Criteria:

  • Emergency procedure
  • Less than 16 years of age
  • Unable to consent
  • Symptomatic gastro-oesophageal reflux disease
  • Evidence of raised intracranial pressure
  • Known pharyngeal pathology
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563301
Other Study ID Numbers  ICMJE 2008AN01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lynsey Foulds, NHS Tayside
Study Sponsor  ICMJE NHS Tayside
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lynsey T Foulds, MBChB NHS Tayside
PRS Account NHS Tayside
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP