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Sore Throat After Intubation Using Glidescope With Stylet and Bougie

Primary Purpose

Postoperative Sore Throat

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
a device to facilitate endotracheal intubation
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Sore Throat

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I, II UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GA

Exclusion Criteria:

  • ANTICIPATED DIFFICULT INTUBATION

Sites / Locations

  • Suez Canal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

stylet

bougie

Arm Description

The stylet is a device that is put inside the endotracheal tube to facilitate its insertion into the trachea

The bougie is a device that is inserted into the trachea and an endotracheal tube is loaded over it and is slide into the trachea

Outcomes

Primary Outcome Measures

postoperative sore throat (POST)
report severity of postoperative sore throat and CHANGES that could occur later on

Secondary Outcome Measures

postoperative sore throat (POST)
INCIDENCE of postoperative sore throat

Full Information

First Posted
April 27, 2020
Last Updated
September 28, 2022
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT04371094
Brief Title
Sore Throat After Intubation Using Glidescope With Stylet and Bougie
Official Title
Comparison Between Using Glidescope With Stylet Technique and With Bougie Technique on the Incidence and Severity of Postoperative Sore Throat Development
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective double-blinded clinical trial aiming to compare the incidence and severity of sore throat after laparoscopic cholecystectomy when using two different techniques of intubation using glidescope
Detailed Description
The first technique is loading the endotracheal tube on a stylet the second technique is sliding the endotracheal tube over a bogie that is dragged into the trachea at both techniques, the investigators are using glidescope

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
double-blinded
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stylet
Arm Type
Active Comparator
Arm Description
The stylet is a device that is put inside the endotracheal tube to facilitate its insertion into the trachea
Arm Title
bougie
Arm Type
Active Comparator
Arm Description
The bougie is a device that is inserted into the trachea and an endotracheal tube is loaded over it and is slide into the trachea
Intervention Type
Device
Intervention Name(s)
a device to facilitate endotracheal intubation
Intervention Description
a device to facilitate endotracheal intubation
Primary Outcome Measure Information:
Title
postoperative sore throat (POST)
Description
report severity of postoperative sore throat and CHANGES that could occur later on
Time Frame
IMMEDIATELY POSTOPERATIVE AND 2 HORSE LATER
Secondary Outcome Measure Information:
Title
postoperative sore throat (POST)
Description
INCIDENCE of postoperative sore throat
Time Frame
immediately postoperative at recovery room

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I, II UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GA Exclusion Criteria: ANTICIPATED DIFFICULT INTUBATION
Facility Information:
Facility Name
Suez Canal University
City
Ismailia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
STILL WORKING ON

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Sore Throat After Intubation Using Glidescope With Stylet and Bougie

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