- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04276831
Comparison Between Laryngoscope McCoy With Macintosh
February 18, 2020 updated by: Riyadh Firdaus, Indonesia University
Comparison of Cardiovascular Response and Ease of Intubation Using Laryngoscope McCoy With Macintosh in Malay Race in Indonesia
This study aimed to compare cardiovascular response and ease of intubation using laryngoscope McCoy with Macintosh
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Eighty-two subjects were given informed consent before enrolling the study and randomized into two groups: McCoy and Macintosh.
Non-invasive blood pressure
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 10430
- Indonesia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Laryngoscope McCoy
Patients will be intubated using laryngoscope McCoy
|
Subjects who fulfill inclusion criteria will be intubated using laryngoscope McCoy
|
|
ACTIVE_COMPARATOR: Laryngoscope Macintosh
Patients will be intubated using laryngoscope Macintosh
|
Subjects who fulfill inclusion criteria will be intubated using laryngoscope Macintosh
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of systolic blood pressure
Time Frame: 3 minutes
|
Measurement of systolic blood pressure by using automated sphygmomanometer and recorded in mmHg
|
3 minutes
|
|
Measurement of diastolic blood pressure
Time Frame: 3 minutes
|
Measurement of diastolic blood pressure by using automated sphygmomanometer and recorded in mmHg
|
3 minutes
|
|
Measurement of mean arterial pressure
Time Frame: 3 minutes
|
Measurement of mean arterial pressure by using automated sphygmomanometer and recorded in mmHg
|
3 minutes
|
|
Measurement of heart rate
Time Frame: 3 minutes
|
Measurement of heart rate and recorded beats per minute
|
3 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concentration of opioid administration for 24 hours after surgery
Time Frame: 24 hours
|
Concentration of opioid administration in mcg
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Riyadh Firdaus, MD, Indonesia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Anaesthesia. 2012 May;67(5):570.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2018
Primary Completion (ACTUAL)
March 4, 2019
Study Completion (ACTUAL)
March 4, 2019
Study Registration Dates
First Submitted
January 8, 2020
First Submitted That Met QC Criteria
February 18, 2020
First Posted (ACTUAL)
February 19, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 19, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- IndonesiaUAnes046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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