Sore Throat After Intubation Using Glidescope With Stylet and Bougie

Comparison Between Using Glidescope With Stylet Technique and With Bougie Technique on the Incidence and Severity of Postoperative Sore Throat Development

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

Study Overview

• Status: Completed
• Conditions: Postoperative Sore Throat
• Intervention / Treatment: Device: a device to facilitate endotracheal intubation

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

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I, II UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GA

Exclusion Criteria:

• ANTICIPATED DIFFICULT INTUBATION

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: stylet; The stylet is a device that is put inside the endotracheal tube to facilitate its insertion into the trachea	Device: a device to facilitate endotracheal intubation; a device to facilitate endotracheal intubation
Active Comparator: bougie; 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	Device: a device to facilitate endotracheal intubation; a device to facilitate endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative sore throat (POST)	report severity of postoperative sore throat and CHANGES that could occur later on	IMMEDIATELY POSTOPERATIVE AND 2 HORSE LATER

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative sore throat (POST)	INCIDENCE of postoperative sore throat	immediately postoperative at recovery room

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: Glidescope and sore throat

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: STILL WORKING ON

Drug and device information, study documents

• 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