Hemodynamic Changes of Tracheal Intubation With McCoy and Macintosh Laryngoscopes

Sponsor
CMH Jhelum (Other)
Overall Status
Completed
CT.gov ID
NCT05133375
Collaborator
(none)
272
1
2
6
45.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tracheal Intubation
N/A

Detailed Description

After taking approval from hospital ethical committee, 272 patients who reported to Operation Theatre of CMH, Jhelum were selected for the study. Informed consent was obtained and patient demographic information (name, age, contact) was recorded. Patients were randomly divided in two equal groups by using lottery method. GROUP A: Where Macintosh laryngoscope was used for endotracheal intubation. GROUP B: Where McCoy laryngoscope was used for endotracheal intubation.

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 3minutes after intubation. All this information was recorded on a Proforma.

Study Design

Study Type:
Interventional
Actual Enrollment :
272 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Comparison of Hemodynamic Changes of Tracheal Intubation With McCoy and Macintosh Laryngoscopes
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Oct 1, 2021
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: GROUP A

Macintosh laryngoscope was used for endotracheal intubation.

Procedure: Tracheal Intubation
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.

Experimental: GROUP B

McCoy laryngoscope was used for endotracheal intubation.

Procedure: Tracheal Intubation
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.

Outcome Measures

Primary Outcome Measures

  1. Effect on the 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.]

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

  2. Effect on the systolic blood pressure of intubation with Macintosh and McCoy laryngoscope [After Laryngoscopy, systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CMH Jhelum Punjab Pakistan 49600

Sponsors and Collaborators

  • CMH Jhelum

Investigators

  • Principal Investigator: Muhammad Awais Qarni, Anesthesiologist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
M. Awais Qarni, Anesthesiologist, CMH Jhelum
ClinicalTrials.gov Identifier:
NCT05133375
Other Study ID Numbers:
  • 11112021
First Posted:
Nov 24, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 24, 2021