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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

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

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

NCT ID

NCT04371094

First Posted

April 27, 2020

Last Updated

September 28, 2022

Sponsor

Suez Canal University

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

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

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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