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Comparison of Hemodynamic Changes by Using the Videolaryngoscope and the Macintosh Laryngoscope

NCT ID: NCT02564640

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-09-30

Brief Summary

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Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope needs comparatively less airway manipulation so, the investigators expect less hemodynamic response while using videolaryngoscope.

Detailed Description

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The hemodynamic stress response to tracheal intubation can precipitate adverse cardiovascular events in patients with cardiovascular disease. Which is shown to greatly increase the risk of myocardial infarction or stroke, especially in elderly patients with hypertension. Direct laryngoscopy and laryngoscopic stimulation of pharyngolaryngeal structures may be an important factor in the hemodynamic stress response associated with tracheal intubation.

Patients were randomly allocated to two groups using a permuted block randomization method: 1) patients intubated by using the videolaryngoscopy 2) patients intubated by using the Macintosh laryngoscope . SAP, MAP, and heart rate were measured and recorded in the operating room: At baseline, before intubation, immediately after intubation and 1,2,3,4 and 5 minutes after tracheal intubation.

Conditions

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Anesthesia Intubation Complication

Keywords

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videolaryngoscope direct laryngoscope hemodynamic changes elderly patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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videolaryngoscope

patients intubated by using the videolaryngoscopy

Group Type ACTIVE_COMPARATOR

videolaryngoscope

Intervention Type DEVICE

patients intubated by using the videolaryngoscope

Macintosh laryngoscope

patients intubated by using the Macintosh laryngoscope

Group Type ACTIVE_COMPARATOR

Macintosh laryngoscope

Intervention Type DEVICE

patients intubated by using the Macintosh laryngoscope

Interventions

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videolaryngoscope

patients intubated by using the videolaryngoscope

Intervention Type DEVICE

Macintosh laryngoscope

patients intubated by using the Macintosh laryngoscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists Physical Status II-III,
* aged over 65 years,
* controlled hypertensive patients,
* scheduled for elective coronary artery bypass grafting.

Exclusion Criteria

* American Society of Anesthesiologists Physical Status IV,
* ejection fraction \< 40%,
* any anatomical abnormality in head, neck or face,
* Mallampati score of IV,
* history of difficult intubation or laryngoscopy
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nilgun Kavrut Ozturk, MD

Role: STUDY_DIRECTOR

Antalya Training and Research Hospital

Locations

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Antalya Training and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kihara S, Brimacombe J, Yaguchi Y, Watanabe S, Taguchi N, Komatsuzaki T. Hemodynamic responses among three tracheal intubation devices in normotensive and hypertensive patients. Anesth Analg. 2003 Mar;96(3):890-895. doi: 10.1213/01.ANE.0000048706.15720.C9.

Reference Type BACKGROUND
PMID: 12598280 (View on PubMed)

Kanaide M, Fukusaki M, Tamura S, Takada M, Miyako M, Sumikawa K. Hemodynamic and catecholamine responses during tracheal intubation using a lightwand device (Trachlight) in elderly patients with hypertension. J Anesth. 2003;17(3):161-5. doi: 10.1007/s00540-003-0166-8.

Reference Type BACKGROUND
PMID: 12911202 (View on PubMed)

Xue FS, Zhang GH, Li XY, Sun HT, Li P, Li CW, Liu KP. Comparison of hemodynamic responses to orotracheal intubation with the GlideScope videolaryngoscope and the Macintosh direct laryngoscope. J Clin Anesth. 2007 Jun;19(4):245-50. doi: 10.1016/j.jclinane.2006.11.004.

Reference Type RESULT
PMID: 17572317 (View on PubMed)

Xue FS, Zhang GH, Li XY, Sun HT, Li P, Sun HY, Xu YC, Liu Y. Comparison of haemodynamic responses to orotracheal intubation with GlideScope videolaryngoscope and fibreoptic bronchoscope. Eur J Anaesthesiol. 2006 Jun;23(6):522-6. doi: 10.1017/S0265021506000299. Epub 2006 Mar 1.

Reference Type RESULT
PMID: 16507195 (View on PubMed)

Other Identifiers

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AntalyaTRH 008

Identifier Type: -

Identifier Source: org_study_id