NCT04276831

Brief Summary

This study aimed to compare cardiovascular response and ease of intubation using laryngoscope McCoy with Macintosh

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable surgery

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

December 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

January 8, 2020

Last Update Submit

February 18, 2020

Conditions

Surgery

Keywords

IntubationCardiovascular responseLaryngoscope

Outcome Measures

Primary Outcomes (4)

  • Measurement of systolic blood pressure

    Measurement of systolic blood pressure by using automated sphygmomanometer and recorded in mmHg

    3 minutes

  • Measurement of diastolic blood pressure

    Measurement of diastolic blood pressure by using automated sphygmomanometer and recorded in mmHg

    3 minutes

  • Measurement of mean arterial pressure

    Measurement of mean arterial pressure by using automated sphygmomanometer and recorded in mmHg

    3 minutes

  • Measurement of heart rate

    Measurement of heart rate and recorded beats per minute

    3 minutes

Secondary Outcomes (1)

  • Concentration of opioid administration for 24 hours after surgery

    24 hours

Study Arms (2)

Laryngoscope McCoy

ACTIVE COMPARATOR

Patients will be intubated using laryngoscope McCoy

Device: Laryngoscope McCoy

Laryngoscope Macintosh

ACTIVE COMPARATOR

Patients will be intubated using laryngoscope Macintosh

Device: Laryngoscope Macintosh

Interventions

Laryngoscope McCoyDEVICE

Subjects who fulfill inclusion criteria will be intubated using laryngoscope McCoy

Laryngoscope McCoy
Laryngoscope MacintoshDEVICE

Subjects who fulfill inclusion criteria will be intubated using laryngoscope Macintosh

Laryngoscope Macintosh

Eligibility Criteria

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

You may qualify if:

  • adults (18 - 65 years old)
  • body mass index 18,5 - 30 kg/m2
  • physical status with ASA 1 -2
  • patients who agreed to participate in this study and sign informed consent.

You may not qualify if:

  • pregnancy
  • history of infarct miocard
  • right or left heart failure
  • P-R interval 0,24 seconds
  • heart block degree 2 or 3
  • using pace maker
  • history of cerebrovascular disease
  • tachycardia or bradycardia
  • on medication (antiarrhythmic drugs, beta blocker, heart stimulant)
  • suspect difficult airways
  • including ventilation (assesment with MOANS) or intubation (assesment with LEMONS)
  • patients with increase of intracranial pressure (e.g.head injury)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indonesia University

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (5)

  • Xue FS, Wang Q, Liao X, Yuan YJ. Cardiovascular intubation responses with Airway Scope and Macintosh laryngoscope. Anaesthesia. 2012 Apr;67(4):434-5; author reply 435-6. doi: 10.1111/j.1365-2044.2012.07071_1.x. No abstract available.

    PMID: 22409804RESULT

  • Randell T. Haemodynamic responses to intubation: what more do we have to know? Acta Anaesthesiol Scand. 2004 Apr;48(4):393-5. doi: 10.1111/j.1399-6576.2004.00381.x. No abstract available.

    PMID: 15025596RESULT

  • Shimoda O, Ikuta Y, Isayama S, Sakamoto M, Terasaki H. Skin vasomotor reflex induced by laryngoscopy: comparison of the McCoy and Macintosh blades. Br J Anaesth. 1997 Dec;79(6):714-8. doi: 10.1093/bja/79.6.714.

    PMID: 9496201RESULT

  • Bilgin H, Bozkurt M. Tracheal intubation using the ILMA, C-Trach or McCoy laryngoscope in patients with simulated cervical spine injury. Anaesthesia. 2006 Jul;61(7):685-91. doi: 10.1111/j.1365-2044.2006.04706.x.

    PMID: 16792615RESULT

  • Noppens RR, Geimer S, Eisel N, David M, Piepho T. Endotracheal intubation using the C-MAC(R) video laryngoscope or the Macintosh laryngoscope: a prospective, comparative study in the ICU. Crit Care. 2012 Jun 13;16(3):R103. doi: 10.1186/cc11384.

    PMID: 22695007RESULT

Study Officials

  • Riyadh Firdaus, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2020

First Posted

February 19, 2020

Study Start

December 1, 2018

Primary Completion

March 4, 2019

Study Completion

March 4, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)