Sore ThroatPOSTNCT04115865
Assessment of Post-operative Sore Throat After Scheduled General Anesthesia
An observational study of Sore Throat and Intubation;Difficult, run by University Hospital, Lille.
Trial summary
Precise description of the technique for intubation or laryngeal mask placement during general anesthesia Research on factors that can influence sore throat due to the placement of an endobuccal or endotracheal device during general anesthesia Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Sore Throat, Intubation;Difficult
- What is being tested?
- Endotracheal sonde or laryngeal mask
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jan 2021
- Phase
- Observational
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient to be operated on in the Department of Surgical Specialties, Neurosurgery, Orthopaedics and Pediatric Surgery at the University Hospital of Lille
Who may be able to join
- General Anesthesia required Endotracheal or endobuccal device
Who cannot join
- Tracheotomy per or post surgery
- Patient with pre-operative pharyngeal irritation.
- Patient with a prior respiratory tract infection.
- Surgery of the laryngeal or tracheal vein, old or new
- Surgery scheduled less than 24 hours ago.
About this study
Precise description of the technique for intubation or laryngeal mask placement during general anesthesia Research on factors that can influence sore throat due to the placement of an endobuccal or endotracheal device during general anesthesia
- Conditions
- Sore Throat, Intubation;Difficult
- Being tested
- Endotracheal sonde or laryngeal mask
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal sonde or laryngeal maskDevice
Healthy subjects ; requiring general anesthesia with endotracheal or endobuccal device
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sore throat
Measured: Within 24 hours of surgery
Secondary outcomes (2)
Severity of sore throat,
Measured: At exit of the post-interventional monitoring room, at 24 hours of surgery or exit of hospital
type of sore throat risk factor
(technique of intubation, analgesic treatment for surgery…)
Measured: At exit of the post-interventional monitoring room, at 24 hours of surgery or exit of hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: refusal ethics comity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elsa Jozefowicz, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115865
- Sponsor's protocol ID
- 2018_96
- Other IDs
- 2019-A02077-50
- Acronym
- POST
- Status last verified
- Mar 2020
- First submitted
- 2 Oct 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Post-operative Sore Throat After Scheduled General Anesthesia
- ClinicalTrials.gov ID
- NCT04115865
- Acronym / sponsor ID
- POST / 2018_96
- Conditions
- Sore Throat, Intubation;Difficult
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: refusal ethics comity
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 4 Oct 2019 (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.
Precise description of the technique for intubation or laryngeal mask placement during general anesthesia Research on factors that can influence sore throat due to the placement of an endobuccal or endotracheal device during general anesthesia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient to be operated on in the Department of Surgical Specialties, Neurosurgery, Orthopaedics and Pediatric Surgery at the University Hospital of Lille
Key inclusion criteria (1 listed)
- General Anesthesia required Endotracheal or endobuccal device
Key exclusion criteria (5 listed)
- Tracheotomy per or post surgery
- Patient with pre-operative pharyngeal irritation.
- Patient with a prior respiratory tract infection.
- Surgery of the laryngeal or tracheal vein, old or new
- Surgery scheduled less than 24 hours ago.
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 sonde or laryngeal maskHealthy subjects ; requiring general anesthesia with endotracheal or endobuccal device | Device | – |
Primary outcome
Incidence of sore throat
Time frame: Within 24 hours of surgery
2 secondary outcomes
Severity of sore throat,
Time frame: At exit of the post-interventional monitoring room, at 24 hours of surgery or exit of hospital
type of sore throat risk factor
Time frame: At exit of the post-interventional monitoring room, at 24 hours of surgery or exit of hospital
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
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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.
Elsa Jozefowicz, MD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Sore Throat and Intubation;Difficult, run by University Hospital, Lille.
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 5 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: withdrawn, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 sore throat (time frame: Within 24 hours of surgery). 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 27 Mar 2020.