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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02664532
Other study ID # PR/JHTMH/09242A
Secondary ID
Status Completed
Phase N/A
First received January 10, 2016
Last updated February 12, 2016
Start date January 2010
Est. completion date December 2010

Study information

Verified date February 2016
Source Tata Main Hospital
Contact n/a
Is FDA regulated No
Health authority India: Indian Council of Medical Research
Study type Interventional

Clinical Trial Summary

The purpose of this prospective open labeled randomized study was to compare the "laryngoscopic glottis view" as well as "ease of intubation" between the two blades in routine intubations in non-difficult airways.


Description:

One hundred and fifty patients with predicted non difficult airway were randomly assigned into two groups. After induction of anaesthesia laryngoscopy was performed with respective blades and trachea intubated. Parameters monitored were: glottis view obtained during laryngoscopy (Cormack Lehane grade), ease of intubation, intubation attempts, total duration of laryngoscopy in seconds and encountered complications.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- All ASA I & II grade patients undergoing elective surgery requiring general anesthesia with oral endotracheal intubation

Exclusion Criteria:

- Patients with anticipated difficult airway

- Cervical spine disorders

- Anesthesia requiring rapid sequence induction

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Miller group
Miller blade was used for laryngoscopy
Macintosh group
Macintosh blade was used for laryngoscopy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tata Main Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Ease of Intubation or Degree of Difficulty With Intubation Degree of difficulty with intubation Grade 1 Intubation easy Grade 2 Intubation requiring an increased anterior lifting force/optimal external laryngeal manipulation (OELM)/assistance to pull the right corner of the mouth upwards to augment space Grade 3 Intubation requiring more than one attempt or bougie guided intubation Grade 4 failure to intubate with the assigned laryngoscope 60 seconds No
Secondary Cormack Lehane Grading Grade 1 Full view of glottis Grade 2 Only posterior commissure visible Grade 3 Only epiglottis visible Grade 4 No glottis structure visible 60 seconds No
Secondary Number of Intubation Attempts An intubation attempt is defined as "intubation activities occurring during a single continuous laryngoscopy maneuver". Thus, even if several attempts were made to place an endotracheal tube during the course of a single laryngoscopy, this would be counted as a single intubation attempt. 180 seconds No
Secondary Total Laryngoscopy Duration in Seconds The duration of intubation was defined as the time taken from placement of the laryngoscope in the mouth to the time taken to remove the laryngoscope from the mouth following intubation. 180 seconds No
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