A Comparative Study of Glidescope Versus Macintosh Laryngoscope in Adult Hypertensive Patients

NCT03316443 | Completed DMC

• 1 other identifier: MS/17.10.93
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodynamic response to laryngoscopy and tracheal intubation remain of utmost concern in anesthesia practice. Sympathetic stimulation and adverse physiologic events could be tolerated by healthy individuals, but they may be detrimental in hypertensive patients. The magnitude of hemodynamic response of intubation is related to the degree of manipulation of the oropharyngeo-laryngeal structures. Unlike Macintosh laryngoscope,Glidescope is a device that does not require alignment of oropharyngeal axis to visualize the glottis.It needs less upward lifting force with less manipulation of pharyngeal structures during the intubation. It was reported that Glidescope had no significant advantage over Macintosh in attenuating circulatory response to endotracheal intubation in normotensive patients.Till now no clinical trials investigate the hemodynamic effects of Glidescope in hypertensive patients.The investigators hypothesized that the Glidescope will induce less hemodynamic changes among hypertensive patients during endotracheal intubation.So the study was designed to compare effects of Glidescope versus Macintosh laryngoscope in hypertensive patients with special regard to hemodynamics and intubation conditions.

Conditions

Hypertensive Patients

Keywords

Glidescope,Macintosh, Laryngscope, intubation,Hypertension.

Outcome Measures

Primary Outcomes (4)

• Arterial blood pressure changes

  Systolic arterial blood pressure changes with the use of each device for endotracheal intubation.

  During 10 minutes after endotracheal inubation.

• Arterial blood pressure changes

  Diastolic arterial blood pressure changes with the use of each device for endotracheal intubation.

  During 10 minutes after endotracheal intubation.

• Arterial blood pressure changes

  Mean arterial blood pressure changes with the use of each device for endotracheal intubation.

  During 10 minutes of trial of endotracheal intubation.

• Heart rate changes

  Heart rate changes with the use of each device for endotracheal intubation.

  During 10 minutes of trial of endotracheal intubation.

Secondary Outcomes (5)

• Success rate of endotracheal intubation with each device.

  During intraoperative trial of endotracheal intubation.

• Endotracheal intubation time with each device.

  During intraoperative trials of endotracheal intubation.

• Attempts of endotracheal intubation with each device.

  During intraoperative trials of endotracheal intubation.

• severity of sore throat with each device.

  24 hours after endotracheal intubation

• severity of hoarseness of voice with each device.

  24 hours after endotracheal intubation

Study Arms (2)

(Group G)

ACTIVE COMPARATOR

Glidescope group: 45 patients will be intubated by Glidescope (Group G). For endotracheal intubation with glidoscope, size 3 blade will be used in all of the cases. Glidoscope will be advanced gently in the oral cavity (in the midline) and walked down the tongue. The scope will be further advanced into the vallecula and gentle lifting force will be applied for visualization of the glottis. Endotracheal tube will be loaded on specific rigid stylet with 60 degree bent and will be advanced into the trachea by the same operator.

Device: Glidescope

(Group M)

EXPERIMENTAL

Macintosh group: 45 patients will be intubated by Macintosh laryngoscope (Group M).The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). In Macintosh group we will use a blade size 3 at first, the laryngoscope will be advanced in patient mouth displacing the tongue laterally till the laryngoscope reach the vallecula and then gentle lifting will be applied till visualization of the laryngeal inlet then the tube will be advanced

Device: Macintosh

Interventions

Glidescope DEVICE

The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). For endotracheal intubation with glidescope, size 3 blade will be used in all of the cases. Glidoscope will be advanced gently in the oral cavity (in the midline) and walked down the tongue. The scope will be further advanced into the vallecula and gentle lifting force will be applied for visualization of the glottis. Endotracheal tube will be loaded on specific rigid stylet with 60 degree bent and will be advanced into the trachea by the same operator. Systolic, diastolic, mean arterial blood pressure and heart rate will be recorded at the following time points: T1: before anesthesia, T2: after induction and immediately before intubation, T3: immediate after completion of intubation, T4: after 1 minute of intubation, T5: after 2 minutes of intubation, T6: after 3 minutes of intubation, T7: after 5 minutes of intubation, T8: after 10 minutes of intubation.

(Group G)

Macintosh DEVICE

The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). In Macintosh group we will use a blade size 3 at first. The laryngoscope will be advanced in patient mouth displacing the tongue laterally till the laryngoscope reach the vallecula and then gentle lifting will be applied till visualization of the laryngeal inlet then the tube will be advanced.Systolic, diastolic, mean arterial blood pressure and heart rate will be recorded at the following time points: T1: before anesthesia, T2: after induction and immediately before intubation, T3: immediate after completion of intubation, T4: after 1 minute of intubation, T5: after 2 minutes of intubation, T6: after 3 minutes of intubation, T7: after 5 minutes of intubation, T8: after 10 minutes of intubation.Maximal arterial blood pressure and heart rate changes will be recorded

(Group M)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged more than 20 year old.
• Patients classified by the American society of anesthesiologist as 2 or 3 with controlled hypertension.
• Patients with body mass index less than 35.
• Mallampati score 1 or 2, thyromental distance more than 4 cm and central incisor interdistance more than 3 cm will included.

You may not qualify if:

• Patient refusal.
• Patient with uncontrolled hypertension (patients diagnosed as uncontrolled hypertension if they have history of hypertension and systolic blood pressure after 3 measures after admission exceeding 150 mmHg despite of regular antihypertensive therapy).
• Patient with major cardiac diseases (e.g cardiomyopathy).
• Patient with cerebrovascular accidents.
• Patient with history of difficult intubation.
• Patients at risk of aspiration who require rapid sequence induction.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura faculty of medicine

Al Mansurah, Dakahlia Governorate, 050, Egypt

Location

Study Officials

• Mahmoud M Othman, MD

  Faculty of Medicine, Mansoura University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Anesthesia and surgical ICU

Model Details: Eligible 90 adult patients will be randomly allocated by a computer-generated randomization sequence into 2 equal groups: Macintosh group: 45 patients will be intubated by Macintosh laryngoscope (Group M). Glidescope group: 45 patients will be intubated by Glidescope (Group G).

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 20, 2017
• Study Start: November 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: December 1, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

EG (1)