NCT02664532

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
1 month until next milestone

Results Posted

Study results publicly available

March 11, 2016

Completed
Last Updated

March 11, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

January 10, 2016

Results QC Date

February 12, 2016

Last Update Submit

February 12, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Cormack Lehane Grading

    60 seconds

  • Number of Intubation Attempts

    180 seconds

  • Total Laryngoscopy Duration in Seconds

    180 seconds

Study Arms (2)

Miller group

EXPERIMENTAL

In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.

Other: Miller group

Macintosh group

OTHER

In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.

Other: Macintosh group

Interventions

Miller blade was used for laryngoscopy

Miller group

Macintosh blade was used for laryngoscopy

Macintosh group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Patients with anticipated difficult airway
  • Cervical spine disorders
  • Anesthesia requiring rapid sequence induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Limitations and Caveats

Blinding of laryngoscope to the laryngoscopist was not possible. The study was conducted in predicted non-difficult airways and cannot be extrapolated in difficult airway situations.

Results Point of Contact

Title
Dr.Deb Sanjay Nag
Organization
Tata Main Hospital

Study Officials

  • Bhanu Pratap Swain, DNB

    Tata Main Hospital, Jamshedpur,India

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Specialist

Study Record Dates

First Submitted

January 10, 2016

First Posted

January 27, 2016

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 11, 2016

Results First Posted

March 11, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share