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Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation

Primary Purpose

Pharyngitis, Endotracheal Intubation, Pain

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Endotracheal intubation

About this trial

This is an interventional diagnostic trial for Pharyngitis focused on measuring Measurement

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

After signing of the informed consent,
ASA physical status I and II
Mallampati class 1& 2,
BMI < 35,
Undergoing elective surgical procedures (not exceeding two hours in duration) requiring ET intubation

Exclusion Criteria:

Patients undergoing day case,
bariatric, cardiac, nasal, oral or head & neck surgeries,
requiring placement of throat pack or nasogastric/ orogastric tube,
patients assigned to rapid sequence induction,
hoarseness,
patients with anticipated difficult intubation,
history of recent upper respiratory tract infection,
history of difficult intubation
psychiatric disorders hindering proper evaluation,
use of steroids (oral or inhalational) or non-steroidal anti-inflammatory drugs within one week of surgery or previous surgery within last two weeks

Sites / Locations

King Saud University, King Khalid University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Arm Label

Glidescope

Macintosh laryngoscope

Bonfill's rigid scope

Air traq

C -Mac scope

flexible fiberoptic scope

Arm Description

Outcomes

Primary Outcome Measures

Incidence of post operative sore throat

Severity of post operative sore throat

Mean arterial pressure after endotracheal intubation

Secondary Outcome Measures

cormack Leehanes grade of laryngeal view

Percentage of glottic opening score (POGO) score

Intubation difficulty score

Patient's satisfaction score

Full Information

NCT ID

NCT02848365

First Posted

July 22, 2016

Last Updated

February 26, 2019

Sponsor

King Saud University

1. Study Identification

Unique Protocol Identification Number

NCT02848365

Brief Title

Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation

Official Title

Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Saud University

4. Oversight

5. Study Description

Brief Summary

Postoperative sore throat (POST) is a common problem following the use of endotracheal intubation during general anaesthesia. It leads to dissatisfaction and discomfort after surgery and can delay a patient's return to normal routine activities. POST has been rated by patients as the eighth most adverse effect in the postoperative period. The incidence of sore throat after endotracheal intubation varies from 14.4-90%. Laryngoscopy and tracheal intubation also leads to hemodynamic stress response. The response can be deleterious in patient with or without cardiac disease. It is related to the degree of manipulation of the airway during endotracheal intubation and has been studied during intubation for some equipment used for endotracheal intubation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pharyngitis, Endotracheal Intubation, Pain

Keywords

Measurement

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

420 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glidescope

Arm Type

Active Comparator

Arm Title

Macintosh laryngoscope

Arm Type

Active Comparator

Arm Title

Bonfill's rigid scope

Arm Type

Active Comparator

Arm Title

Air traq

Arm Type

Active Comparator

Arm Title

C -Mac scope

Arm Type

Active Comparator

Arm Title

flexible fiberoptic scope

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Endotracheal intubation

Intervention Description

Endotracheal intubation will be done with any of these equipments

Primary Outcome Measure Information:

Title

Incidence of post operative sore throat

Time Frame

0 hours after surgery

Title

Incidence of post operative sore throat

Time Frame

6 hours after surgery

Title

Incidence of post operative sore throat

Time Frame

12 hours after surgery

Title

Incidence of post operative sore throat

Time Frame

24 hours after surgery

Title

Severity of post operative sore throat

Time Frame

0 hours after surgery

Title

Severity of post operative sore throat

Time Frame

6 hours after surgery

Title

Severity of post operative sore throat

Time Frame

12 hours after surgery

Title

Severity of post operative sore throat

Time Frame

24 hours after surgery

Title

Mean arterial pressure after endotracheal intubation

Time Frame

1 minute after surgery

Title

Mean arterial pressure after endotracheal intubation

Time Frame

2 minutes after surgery

Title

Mean arterial pressure after endotracheal intubation

Time Frame

3 minutes after surgery

Title

Mean arterial pressure after endotracheal intubation

Time Frame

4 minutes after surgery

Title

Mean arterial pressure after endotracheal intubation

Time Frame

5 minutes after surgery

Secondary Outcome Measure Information:

Title

cormack Leehanes grade of laryngeal view

Time Frame

At the time of intubation

Title

Percentage of glottic opening score (POGO) score

Time Frame

At the time of intubation

Title

Intubation difficulty score

Time Frame

At the time of intubation

Title

Patient's satisfaction score

Time Frame

After 24 hours of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: After signing of the informed consent, ASA physical status I and II Mallampati class 1& 2, BMI < 35, Undergoing elective surgical procedures (not exceeding two hours in duration) requiring ET intubation Exclusion Criteria: Patients undergoing day case, bariatric, cardiac, nasal, oral or head & neck surgeries, requiring placement of throat pack or nasogastric/ orogastric tube, patients assigned to rapid sequence induction, hoarseness, patients with anticipated difficult intubation, history of recent upper respiratory tract infection, history of difficult intubation psychiatric disorders hindering proper evaluation, use of steroids (oral or inhalational) or non-steroidal anti-inflammatory drugs within one week of surgery or previous surgery within last two weeks

Facility Information:

Facility Name

King Saud University, King Khalid University Hospital

City

Riyadh

ZIP/Postal Code

11472

Country

Saudi Arabia

12. IPD Sharing Statement

Citations:

PubMed Identifier

28899338

Citation

Aqil M, Khan MU, Mansoor S, Mansoor S, Khokhar RS, Narejo AS. Incidence and severity of postoperative sore throat: a randomized comparison of Glidescope with Macintosh laryngoscope. BMC Anesthesiol. 2017 Sep 12;17(1):127. doi: 10.1186/s12871-017-0421-4. Erratum In: BMC Anesthesiol. 2018 Aug 17;18(1):112.

Results Reference

derived

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Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation

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