Postoperative Sore ThroatNCT04371094
Sore Throat After Intubation Using Glidescope With Stylet and Bougie
A study testing a device to facilitate endotracheal intubation in people with Postoperative Sore Throat, run by Suez Canal University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- a device to facilitate endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I, II UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GA
Who cannot join
- ANTICIPATED DIFFICULT INTUBATION
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Postoperative Sore Throat
- Being tested
- a device to facilitate endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a device to facilitate endotracheal intubationDevice
a device to facilitate endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| stylet | Active comparator | The stylet is a device that is put inside the endotracheal tube to facilitate its insertion into the trachea Receives: Device: a device to facilitate endotracheal intubation |
| bougie | Active comparator | 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 Receives: Device: a device to facilitate endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative sore throat (POST)
report severity of postoperative sore throat and CHANGES that could occur later on
Measured: IMMEDIATELY POSTOPERATIVE AND 2 HORSE LATER
Secondary outcomes (1)
postoperative sore throat (POST)
INCIDENCE of postoperative sore throat
Measured: immediately postoperative at recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Jan 2020
- Primary completion30 Mar 2020
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371094
- Sponsor's protocol ID
- Glidescope and sore throat
- Status last verified
- Sep 2022
- First submitted
- 27 Apr 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: STILL WORKING ON
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Using Glidescope With Stylet Technique and With Bougie Technique on the Incidence and Severity of Postoperative Sore Throat Development
- ClinicalTrials.gov ID
- NCT04371094
- Acronym / sponsor ID
- Glidescope and sore throat
- Conditions
- Postoperative Sore Throat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stylet | Active comparator | Device: a device to facilitate endotracheal intubationThe stylet is a device that is put inside the endotracheal tube to facilitate its insertion into the trachea |
| bougie | Active comparator | Device: a device to facilitate endotracheal intubationThe bougie is a device that is inserted into the trachea and an endotracheal tube is loaded over it and is slide into the trachea |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I, II UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GA
Key exclusion criteria (1 listed)
- ANTICIPATED DIFFICULT INTUBATION
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a device to facilitate endotracheal intubationa device to facilitate endotracheal intubation | Device | bougie, stylet |
Primary outcome
postoperative sore throat (POST)
Time frame: IMMEDIATELY POSTOPERATIVE AND 2 HORSE LATER
report severity of postoperative sore throat and CHANGES that could occur later on
1 secondary outcome
postoperative sore throat (POST)
Time frame: immediately postoperative at recovery room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: Undecided. STILL WORKING ON
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a device to facilitate endotracheal intubation in people with Postoperative Sore Throat, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative sore throat (POST) (time frame: IMMEDIATELY POSTOPERATIVE AND 2 HORSE LATER). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.