NCT01352299

Brief Summary

Orotracheal intubation the commonest method used to secure and maintain airway during anaesthesia. A variety of methods are available for orotracheal intubation such as digital or tactile method, use of lighted orotracheal intubating stylet, use of intubating LMA (which is becoming increasing popular, particularly in cased of anticipated difficult intubation), fibreoptic endoscopic orotracheal intubation (also used when a difficulty is predicted), and conventional and most common method, direct laryngoscopy. Orotracheal intubation is most commonly achieved after visualization of laryngeal inlet with direct laryngoscopy following induction of general anaesthesia and muscle relaxation achieved by administration of a muscle relaxant. Due to the hazards seen with failed intubation, anaesthetists are also on the lookout for techniques which will improve visualization of the laryngeal inlet, i.e. glottis. View obtained during laryngoscopy can be classified in a variety of ways such as Cormack Lehane grading, the percentage of glottic opening (POGO Score)Literature suggests that straight blade gives better glottic visualization while tracheal intubation is easier with the curved blade. We therefore wanted to compare the Macintosh and Miller laryngoscope blades in terms of visualization of Laryngeal inlet and ease of intubation in patients with normal predicted intubation. We also compared the McCoy blade, a modified curved blade, and the Trueview Laryngoscope, which incorporates a prism in a straight blade, for glottic view and ease of intubation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
Last Updated

May 11, 2011

Status Verified

May 1, 2011

Enrollment Period

2 months

First QC Date

May 9, 2011

Last Update Submit

May 10, 2011

Conditions

Tracheal Intubation Morbidity

Keywords

Macintosh laryngoscope bladeMacCoy laryngoscope bladeMiller laryngoscope bladeTrueView laryngoscope

Outcome Measures

Primary Outcomes (1)

  • Visualization of glottis and Ease of Intubation

    Visualization of laryngeal inlet: Grade 1: complete glottis visible Grade 2: anterior glottis not seen Grade 3: epiglottis seen but not glottis Grade 4: epiglottis not seen Ease of intubation: Grade 1: Intubation easy Grade 2: Intubation requiring an increased anterior lifting force and assistance to pull the right corner of the mouth upwards to increase space Grade 3: Intubation requiring multiple attempts and a curved stylet Grade 4: Failure to intubate with the assigned laryngoscope

    During Laryngoscopy and intubation average time 1 minute

Study Arms (4)

Macintosh

ACTIVE COMPARATOR

Laryngoscopy performed with Macintosh Laryngoscope

Device: Macintosh Laryngoscope blade

McCoy

ACTIVE COMPARATOR

Laryngoscopy performed with MacCoy Laryngoscope

Device: MacCoy

Miller

ACTIVE COMPARATOR

Laryngoscopy performed with Miller Laryngoscope

Device: Miller

TrueView

ACTIVE COMPARATOR

Laryngoscopy performed with TrueView Laryngoscope

Device: TrueView

Interventions

Macintosh Laryngoscope bladeDEVICE

Laryngoscopy performed with Macintosh Laryngoscope

Also known as: Conventional Curved laryngoscope blade
Macintosh
MacCoyDEVICE

Laryngoscopy performed with MacCoy Laryngoscope

Also known as: Curved laryngoscope blade with a hinged tip
McCoy
MillerDEVICE

Laryngoscopy performed with Miller Laryngoscope

Also known as: Conventional Straight laryngoscope blade
Miller
TrueViewDEVICE

Laryngoscopy performed with TrueView laryngoscope

Also known as: Straight blade with prism
TrueView

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in the age group of 18-70 yrs
  • Patients with ASA grade I and II
  • Undergoing surgery under general anaesthesia requiring endotracheal intubation.

You may not qualify if:

  • Patient's refusal for consent for study.
  • Patients less than 18 years and more than 70years of age.
  • Pregnant patients
  • Patients with difficult mask ventilation and /or anticipated difficult intubation
  • Patients with pathology in neck, upper respiratory tract and upper alimentary tract.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hopsital

Mumbai, Maharashtra, 400012, India

Location

Study Officials

  • Atul P Kulkarni, MD Anaes

    Professor Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 11, 2011

Study Start

August 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

May 11, 2011

Record last verified: 2011-05

Locations

IN(1)