Anesthesia MorbidityPOSTNCT03389776
Postoperative Sore Throat in the Pediatric Population.
An observational study of Anesthesia Morbidity and Sore Throat, run by Istituto Giannina Gaslini at 1 site in United Kingdom.
Trial summary
Endotracheal tubes (ETT) and laryngeal mask airways (LMA) are devices used to help breathing whilst patients are asleep for surgery. Children may have a more satisfying experience if the rate of of post operative sore throat (POST) and hoarseness (PH) could be reduced. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Anesthesia Morbidity, Sore Throat
- What is being tested?
- Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 197 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2017to 31 Mar 2018
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A cohort of minimum 255 children will be prospectively collected from the elective surgical lists of Great Ormond Street Hospital, London, UK. Children 5 years of age or greater, scheduled for surgical procedures will be included.
Who may be able to join
- Child age 5 or over
- General anaesthesia with LMA or ETT
- Children undergoing general, orthopaedic, urology, renal or plastic surgery
Who cannot join
- Other types of surgery
- Patients aged less than 5 years
- Patients affected by a significant cognitive delay
- Patients planned for anaesthesia with airway devices different from ETT and LMA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Postoperative Sore Throat in the Pediatric Population. An Observational Cohort Prospective Study
Endotracheal tubes (ETT) and laryngeal mask airways (LMA) are devices used to help breathing whilst patients are asleep for surgery. Children may have a more satisfying experience if the rate of of post operative sore throat (POST) and hoarseness (PH) could be reduced. The incidence of POST and PH may be as high as 42% in children undergoing anesthesia. ETTs and LMAs require inflation of a cuff after insertion to obtain a seal to a patient's airway for them to be effective. It is recommended that cuff pressures are checked after insertion and inflation with a pressure checking device but this does not occur in all routine anesthetic practice. Overinflation of these cuffs may cause damage to the airway by exerting pressure on surrounding structures. Studies have shown both children and adults to have increased risk of POST with higher LMA pressure. The number of times it takes to successfully insert a LMA has also been associated with POST as has female gender and older age.
Similarly to LMAs, multiple insertion attempts of ETT insertion, female gender and a larger size are more likely to cause POST and PH.
Read more
Although patients with uncuffed have a higher incidence of POST than those with a cuffed ETT, when using cuffed tubes ETT, POST occurs more often as cuff pressure increases and should therefore be routinely measured.
The location of a patient's sore throat may vary. It may be intermittent or constant, or described as difficulty in swallowing, painful swallowing or hoarse voice and may there may be difference locations within the throat. In the current literature there is no one definition of what constitutes a sore throat or how or when it should be measured.
The hypothesis is that occurrence and severity of POST could be determined by various factors other than the pressure of the cuff alone. In particular, the pressure of cuff, the duration of anesthesia, the airway manipulations, could all be factors determining the occurrence of postoperative sore throat.
Based on the above hypothesis, Investigators planed to perform a prospective cohort study.
Aims: to determine the occurrence and severity of post-anaesthesia sore throat in children undergoing surgical procedures with LMA or ETT placement.
If clear factors are demonstrated for POST and PH in pediatric population then measures can be taken to reduce them and thereby improve outcome and patient satisfaction.
Read the detailed description
The study is a prospective, descriptive study, involving patient interview and objective data collected as part of routine anesthetic care. No intervention will take place. Once identified from a theatre list, patients/parents will be approached preoperatively and consent taken to participate. If inclusion criteria are met and consent gained the preoperative questionnaire will be completed to obtain information regarding pain, nausea, sore throat, itching, thirst and hunger. Each symptom will be graded none, mild, moderate, severe. Intraoperative data will be collected after surgery whilst the child is in the recovery room. This is objective data obtained from the anesthetic chart. Prior to discharge to the ward the child will undergo a second interview answering the same questions as he/she did preoperatively (a further 1-2 minutes). Any child who has a sore throat in the recovery room will then be followed up 2 hours later on the ward with a further questionnaire. This will include questions about the location of the sore throat, severity and voice changes (5-10 mins). This will be the end of the participants input.
- Conditions
- Anesthesia Morbidity, Sore Throat
- Being tested
- Anesthesia
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnesthesiaProcedure or surgery
Occurrence and severity of postoperative sore throat could be determined by various factors other than the pressure of the cuff alone. In particular, cuff pressure measurement, duration of anaesthesia, airway manipulations e.g. multiple insertion attempts, could all be factors determining the occurrence of postoperative sore throat.
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of sore throat
No pain, minimal pain, mild pain, severe pain
Measured: Six hours after anesthesia
Secondary outcomes (5)
Stridor
Y/N
Measured: 6 hours after anesthesia
Laryngospasm
Y/N
Measured: 6 hours after anesthesia
Oxygen desaturation
Y/N
Measured: 6 hours after anesthesia
Time to oral intake
Hours
Measured: 6 hours after anesthesia
Hospital discharge
Hours
Measured: 6 hours after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start1 Dec 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia MorbidityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Responsible party
- Principal investigator, Nicola Disma, MD, Istituto Giannina Gaslini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389776
- Sponsor's protocol ID
- 2276
- Acronym
- POST
- Status last verified
- Aug 2019
- First submitted
- 18 Dec 2017
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Sore Throat in the Pediatric Population. An Observational Cohort Prospective Study
- ClinicalTrials.gov ID
- NCT03389776
- Acronym / sponsor ID
- POST / 2276
- Conditions
- Anesthesia Morbidity, Sore Throat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 4 Jan 2018 (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.
Endotracheal tubes (ETT) and laryngeal mask airways (LMA) are devices used to help breathing whilst patients are asleep for surgery. Children may have a more satisfying experience if the rate of of post operative sore throat (POST) and hoarseness (PH) could be reduced. The incidence of POST and PH may be as high as 42% in children undergoing anesthesia. ETTs and LMAs require inflation of a cuff after insertion to obtain a seal to a patient's airway for them to be effective. It is recommended that cuff pressures are checked after insertion and inflation with a pressure checking device but this does not occur in all routine anesthetic practice. Overinflation of these cuffs may cause damage to the airway by exerting pressure on surrounding structures. Studies have shown both children and adults to have increased risk of POST with higher LMA pressure. The number of times it takes to successfully insert a LMA has also been associated with POST as has female gender and older age.
Similarly to LMAs, multiple insertion attempts of ETT insertion, female gender and a larger size are more likely to cause POST and PH.
Although patients with uncuffed have a higher incidence of POST than those with a cuffed ETT, when using cuffed tubes ETT, POST occurs more often as cuff pressure increases and should therefore be routinely measured.
The location of a patient's sore throat may vary. It may be intermittent or constant, or described as difficulty in swallowing, painful swallowing or hoarse voice and may there may be difference locations within the throat. In the current literature there is no one definition of what constitutes a sore throat or how or when it should be measured.
The hypothesis is that occurrence and severity of POST could be determined by various factors other than the pressure of the cuff alone. In particular, the pressure of cuff, the duration of anesthesia, the airway manipulations, could all be factors determining the occurrence of postoperative sore throat.
Based on the above hypothesis, Investigators planed to perform a prospective cohort study.
Aims: to determine the occurrence and severity of post-anaesthesia sore throat in children undergoing surgical procedures with LMA or ETT placement.
If clear factors are demonstrated for POST and PH in pediatric population then measures can be taken to reduce them and thereby improve outcome and patient satisfaction.
Detailed description
The study is a prospective, descriptive study, involving patient interview and objective data collected as part of routine anesthetic care. No intervention will take place. Once identified from a theatre list, patients/parents will be approached preoperatively and consent taken to participate. If inclusion criteria are met and consent gained the preoperative questionnaire will be completed to obtain information regarding pain, nausea, sore throat, itching, thirst and hunger. Each symptom will be graded none, mild, moderate, severe. Intraoperative data will be collected after surgery whilst the child is in the recovery room. This is objective data obtained from the anesthetic chart. Prior to discharge to the ward the child will undergo a second interview answering the same questions as he/she did preoperatively (a further 1-2 minutes). Any child who has a sore throat in the recovery room will then be followed up 2 hours later on the ward with a further questionnaire. This will include questions about the location of the sore throat, severity and voice changes (5-10 mins). This will be the end of the participants input.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A cohort of minimum 255 children will be prospectively collected from the elective surgical lists of Great Ormond Street Hospital, London, UK. Children 5 years of age or greater, scheduled for surgical procedures will be included.
Key inclusion criteria (3 listed)
- Child age 5 or over
- General anaesthesia with LMA or ETT
- Children undergoing general, orthopaedic, urology, renal or plastic surgery
Key exclusion criteria (4 listed)
- Other types of surgery
- Patients aged less than 5 years
- Patients affected by a significant cognitive delay
- Patients planned for anaesthesia with airway devices different from ETT and LMA
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 |
|---|---|---|
| AnesthesiaOccurrence and severity of postoperative sore throat could be determined by various factors other than the pressure of the cuff alone. In particular, cuff pressure measurement, duration of anaesthesia, airway manipulations e.g. multiple insertion attempts, could all be factors determining the occurrence of postoperative sore throat. | Procedure or surgery | – |
Primary outcome
Occurrence of sore throat
Time frame: Six hours after anesthesia
No pain, minimal pain, mild pain, severe pain
5 secondary outcomes
Stridor
Time frame: 6 hours after anesthesia
Laryngospasm
Time frame: 6 hours after anesthesia
Oxygen desaturation
Time frame: 6 hours after anesthesia
Time to oral intake
Time frame: 6 hours after anesthesia
Hospital discharge
Time frame: 6 hours after anesthesia
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 8 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Anesthesia Morbidity and Sore Throat, run by Istituto Giannina Gaslini at 1 site in United Kingdom.
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 3 inclusion and 4 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 8 Aug 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 United Kingdom. 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?
Occurrence of sore throat (time frame: Six hours after anesthesia). 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 8 Aug 2019.