Hemodynamic Responses to Tracheal Intubation Direct Laryngoscope and Videolaryngoscope in Elderly Patients

NCT02816775 | Completed

• 1 other identifier: Ulku2
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The intubation response to airway manipulation during direct laryngoscopy can cause hypertension, dysrhythmias and increased intracranial and intraocular pressures. This intense physiological response is proven to be associated with adverse outcomes especially in elderly patients. Increased QT dispersion is associated with increased risk of ventricular arrhythmias, which may increase the risk of sudden death caused by life-threatening arrhythmias. McGrath Videolaryngoscope would generate a lesser haemodynamic response than the conventional method of direct laryngoscopy. The objective of this study was to compare the hemodynamic response and QT during following tracheal intubation, using videolaryngoscope or direct laryngoscope to intubation. The postoperative airway morbidities is the investigators secondary outcome.

Conditions

Aged Patients

Keywords

hemodynamics; QT interval

Outcome Measures

Primary Outcomes (1)

• mean blood pressure

  The patient's blood pressure should be measured and recorded at 5-minute intervals during the first 30 minutes of the operation.

  Change from baseline mean blood pressure at 30 minutes

Secondary Outcomes (3)

• QT interval

  Change from baseline QT interval at 30 minutes

• heart rate

  Change from baseline heart rate at 30 minutes

• Number of participants with treatment-related adverse events as assessed by 4- point scale

  From extubation until postoperative 24 hours

Study Arms (2)

Group Laryngoscope

ACTIVE COMPARATOR

Group Laryngoscope; intubation will be made by Macintosh laryngoscope

Device: Macintosh Laryngoscope

Group Videolaryngoscope

ACTIVE COMPARATOR

Group Videolaryngoscope; intubation will be made by McGRATH Videolaryngoscope

Device: McGRATH Videolaryngoscope

Interventions

Macintosh Laryngoscope DEVICE

After induction of anesthesia, tracheal intubation will made by Macintosh Laryngoscope

Group Laryngoscope

McGRATH Videolaryngoscope DEVICE

After induction of anesthesia, tracheal intubation will made by McGRATH Videolaryngoscope

Group Videolaryngoscope

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• scheduled for elective surgery under general anesthesia requiring tracheal intubation

You may not qualify if:

• hypertension,
• cardiopulmonary disease,
• diabetes mellitus,
• a predicted problematic airway,
• morbid obesity,
• the use of medications known to affect blood pressure and heart rate as β-adrenergic blockers

Sponsors & Collaborators

• Inonu University: lead

Related Publications (1)

• Tempe DK, Chaudhary K, Diwakar A, Datt V, Virmani S, Tomar AS, Mohandas A, Mohire VB. Comparison of hemodynamic responses to laryngoscopy and intubation with Truview PCD, McGrath(R) and Macintosh laryngoscope in patients undergoing coronary artery bypass grafting: A randomized prospective study. Ann Card Anaesth. 2016 Jan-Mar;19(1):68-75. doi: 10.4103/0971-9784.173023.

  PMID: 26750677 RESULT

Study Officials

• Türkan Toğal, Prof.

  Inonu University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share