NCT02564640

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

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

June 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
Last Updated

December 9, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

September 28, 2015

Last Update Submit

December 8, 2015

Conditions

Anesthesia Intubation Complication

Keywords

videolaryngoscopedirect laryngoscopehemodynamic changeselderly patients

Outcome Measures

Primary Outcomes (1)

  • Blood pressure changes during tracheal intubation ( mmHg ) ,

    At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation

Secondary Outcomes (3)

  • Heart rate changes during tracheal intubation (beats per minute)

    At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation

  • ST segment elevation in electrocardiogram indicating myocardial ischaemia during tracheal intubation

    At baseline, 1 and 5 minutes after tracheal intubation.

  • Arrhythmic changes in electrocardiogram during tracheal intubation

    At baseline, 1 and 5 minutes after tracheal intubation.

Study Arms (2)

videolaryngoscope

ACTIVE COMPARATOR

patients intubated by using the videolaryngoscopy

Device: videolaryngoscope

Macintosh laryngoscope

ACTIVE COMPARATOR

patients intubated by using the Macintosh laryngoscope

Device: Macintosh laryngoscope

Interventions

videolaryngoscopeDEVICE

patients intubated by using the videolaryngoscope

videolaryngoscope
Macintosh laryngoscopeDEVICE

patients intubated by using the Macintosh laryngoscope

Macintosh laryngoscope

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 12598280BACKGROUND

  • 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.

    PMID: 12911202BACKGROUND

  • 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.

    PMID: 17572317RESULT

  • 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.

    PMID: 16507195RESULT

Study Officials

  • Nilgun Kavrut Ozturk, MD

    Antalya Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 1, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-06

Locations

TU(1)