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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04276831
Other study ID # IndonesiaUAnes046
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date March 4, 2019

Study information

Verified date February 2020
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Eighty-two subjects were given informed consent before enrolling the study and randomized into two groups: McCoy and Macintosh. Non-invasive blood pressure


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date March 4, 2019
Est. primary completion date March 4, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria :

- 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.

Exclusion Criteria:

- 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Laryngoscope McCoy
Subjects who fulfill inclusion criteria will be intubated using laryngoscope McCoy
Laryngoscope Macintosh
Subjects who fulfill inclusion criteria will be intubated using laryngoscope Macintosh

Locations

Country Name City State
Indonesia Indonesia University Jakarta DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

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. — View Citation

Noppens RR, Geimer S, Eisel N, David M, Piepho T. Endotracheal intubation using the C-MAC® 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. — View Citation

Randell T. Haemodynamic responses to intubation: what more do we have to know? Acta Anaesthesiol Scand. 2004 Apr;48(4):393-5. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of systolic blood pressure Measurement of systolic blood pressure by using automated sphygmomanometer and recorded in mmHg 3 minutes
Primary Measurement of diastolic blood pressure Measurement of diastolic blood pressure by using automated sphygmomanometer and recorded in mmHg 3 minutes
Primary Measurement of mean arterial pressure Measurement of mean arterial pressure by using automated sphygmomanometer and recorded in mmHg 3 minutes
Primary Measurement of heart rate Measurement of heart rate and recorded beats per minute 3 minutes
Secondary Concentration of opioid administration for 24 hours after surgery Concentration of opioid administration in mcg 24 hours
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