NCT05133375

Brief Summary

A total of 272 patients were randomly allocated into two groups, Patients in group A were treated with Macintosh laryngoscope and in groups B with McCoy laryngoscope was used for endotracheal intubation. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3minutes after intubation. All this information was recorded on a Pro forma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 11, 2021

Last Update Submit

November 23, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Effect on the pulse of intubation with Macintosh and McCoy laryngoscope

    To measure hemodynamic changes (i.e. pulse) of intubation with Macintosh and McCoy laryngoscope

    After Laryngoscopy, pulse was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.

  • Effect on the systolic blood pressure of intubation with Macintosh and McCoy laryngoscope

    To measure hemodynamic changes (i.e. systolic blood pressure) of intubation with Macintosh and McCoy

    After Laryngoscopy, systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation

Study Arms (2)

GROUP A

EXPERIMENTAL

Macintosh laryngoscope was used for endotracheal intubation.

Procedure: Tracheal Intubation

GROUP B

EXPERIMENTAL

McCoy laryngoscope was used for endotracheal intubation.

Procedure: Tracheal Intubation

Interventions

Before reporting to Operation theatre, a detailed pre anesthesia assessment was done in all patients, all necessary laboratory investigations were collected. On OT table pulse and systolic blood pressure was checked by non-invasive method. 18G cannula was passed and ECG was attached. A pillow was placed under the head to obtain classical sniffing position for intubation. All the patients were pre medicated with injection midazolam 0.08mg/kg, injection nalbuphine 0.1 mg/kg, injection dexamethasone 0.08mg/kg and injection metoclopramide 0.1 mg/kg. Pre oxygenation was done with 100% oxygen for 3 mins. Induction was done with injection propofol2 mg/kg, muscle relaxation achieved with injection atracurium 0.5mg/kg. Laryngoscopy was started after 3 minutes by a qualified anesthetist. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.

GROUP AGROUP B

Eligibility Criteria

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

You may qualify if:

  • Both Male and Female
  • Age between 18 to 70
  • ASA I and II males and females.
  • Malampatti I and II.
  • Hemodynamically stable, no known ischemic heart disease and no history of hypertension.
  • Nil per oral for at least 6 hours.

You may not qualify if:

  • Non consenting patient.
  • ASA III, IV or V patient.
  • Malampati III or IV.
  • Cervical instability
  • Thyromental distance of less than 6cm, inter incisor distance of less than 3cm.
  • Known case of hypertension and ischemic heart disease.
  • Pregnant female.
  • Body mass index of more than 30.
  • Patients of oropharyngeal surgery.
  • Unable to Intubate in less than 1 minute.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH

Jhelum, Punjab Province, 49600, Pakistan

Location

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Muhammad Awais Qarni

    Anesthesiologist

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 24, 2021

Study Start

April 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 24, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Overall results will be shared.

Locations