PharyngitisNCT02848365
Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation
A study testing Endotracheal intubation in people with Pharyngitis and Endotracheal Intubation, run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharyngitis, Endotracheal Intubation, Pain
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jun 2011to Aug 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Saud University, King Khalid University Hospital
Riyadh, 11472
About this study
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
- Conditions
- Pharyngitis, Endotracheal Intubation, Pain
- Being tested
- Endotracheal intubation
- Keywords
- Measurement
- Medical subject headings
- Pharyngitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationDevice
Endotracheal intubation will be done with any of these equipments
| Study group | Role | What they receive |
|---|---|---|
| Glidescope | Active comparator | Not described Receives: Device: Endotracheal intubation |
| Macintosh laryngoscope | Active comparator | Not described Receives: Device: Endotracheal intubation |
| Bonfill's rigid scope | Active comparator | Not described Receives: Device: Endotracheal intubation |
| Air traq | Active comparator | Not described Receives: Device: Endotracheal intubation |
| C -Mac scope | Active comparator | Not described Receives: Device: Endotracheal intubation |
| flexible fiberoptic scope | Active comparator | Not described Receives: Device: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post operative sore throat
Measured: 0 hours after surgery
Incidence of post operative sore throat
Measured: 6 hours after surgery
Incidence of post operative sore throat
Measured: 12 hours after surgery
Incidence of post operative sore throat
Measured: 24 hours after surgery
Severity of post operative sore throat
Measured: 0 hours after surgery
Severity of post operative sore throat
Measured: 6 hours after surgery
Severity of post operative sore throat
Measured: 12 hours after surgery
Severity of post operative sore throat
Measured: 24 hours after surgery
Mean arterial pressure after endotracheal intubation
Measured: 1 minute after surgery
Mean arterial pressure after endotracheal intubation
Measured: 2 minutes after surgery
Mean arterial pressure after endotracheal intubation
Measured: 3 minutes after surgery
Mean arterial pressure after endotracheal intubation
Measured: 4 minutes after surgery
Mean arterial pressure after endotracheal intubation
Measured: 5 minutes after surgery
Secondary outcomes (4)
cormack Leehanes grade of laryngeal view
Measured: At the time of intubation
Percentage of glottic opening score (POGO) score
Measured: At the time of intubation
Intubation difficulty score
Measured: At the time of intubation
Patient's satisfaction score
Measured: After 24 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJun 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansoor Aqil, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848365
- Sponsor's protocol ID
- E-11-398
- Status last verified
- Feb 2019
- First submitted
- 22 Jul 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
Publications
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.
PubMed 28899338
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT02848365
- Acronym / sponsor ID
- E-11-398
- Conditions
- Pharyngitis, Endotracheal Intubation, Pain
- Keywords
- Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Glidescope | Active comparator | Device: Endotracheal intubation |
| Macintosh laryngoscope | Active comparator | Device: Endotracheal intubation |
| Bonfill's rigid scope | Active comparator | Device: Endotracheal intubation |
| Air traq | Active comparator | Device: Endotracheal intubation |
| C -Mac scope | Active comparator | Device: Endotracheal intubation |
| flexible fiberoptic scope | Active comparator | Device: Endotracheal intubation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| Endotracheal intubationEndotracheal intubation will be done with any of these equipments | Device | Air traq, Bonfill's rigid scope, C -Mac scope, Glidescope, Macintosh laryngoscope, flexible fiberoptic scope |
Primary outcome
Incidence of post operative sore throat
Time frame: 0 hours after surgery
Incidence of post operative sore throat
Time frame: 6 hours after surgery
Incidence of post operative sore throat
Time frame: 12 hours after surgery
Incidence of post operative sore throat
Time frame: 24 hours after surgery
Severity of post operative sore throat
Time frame: 0 hours after surgery
Severity of post operative sore throat
Time frame: 6 hours after surgery
Severity of post operative sore throat
Time frame: 12 hours after surgery
Severity of post operative sore throat
Time frame: 24 hours after surgery
Mean arterial pressure after endotracheal intubation
Time frame: 1 minute after surgery
Mean arterial pressure after endotracheal intubation
Time frame: 2 minutes after surgery
Mean arterial pressure after endotracheal intubation
Time frame: 3 minutes after surgery
Mean arterial pressure after endotracheal intubation
Time frame: 4 minutes after surgery
Mean arterial pressure after endotracheal intubation
Time frame: 5 minutes after surgery
4 secondary outcomes
cormack Leehanes grade of laryngeal view
Time frame: At the time of intubation
Percentage of glottic opening score (POGO) score
Time frame: At the time of intubation
Intubation difficulty score
Time frame: At the time of intubation
Patient's satisfaction score
Time frame: After 24 hours of surgery
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 27 Feb 2019.
- Derived from this study: PubMed 28899338Aqil 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.
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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 Endotracheal intubation in people with Pharyngitis and Endotracheal Intubation, run by King Saud University at 1 site in Saudi Arabia.
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 5 inclusion and 10 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 27 Feb 2019. 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 Saudi Arabia. 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?
Incidence of post operative sore throat (time frame: 0 hours after surgery). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848365, which also lists 1 linked publication.
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 27 Feb 2019.