- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03389776
Postoperative Sore Throat in the Pediatric Population. (POST)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, WC1N 3JH
- Great Ormond Street Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Child age 5 or over
- General anaesthesia with LMA or ETT
- Children undergoing general, orthopaedic, urology, renal or plastic surgery
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of sore throat
Time Frame: Six hours after anesthesia
|
No pain, minimal pain, mild pain, severe pain
|
Six hours after anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stridor
Time Frame: 6 hours after anesthesia
|
Y/N
|
6 hours after anesthesia
|
Laryngospasm
Time Frame: 6 hours after anesthesia
|
Y/N
|
6 hours after anesthesia
|
Oxygen desaturation
Time Frame: 6 hours after anesthesia
|
Y/N
|
6 hours after anesthesia
|
Time to oral intake
Time Frame: 6 hours after anesthesia
|
Hours
|
6 hours after anesthesia
|
Hospital discharge
Time Frame: 6 hours after anesthesia
|
Hours
|
6 hours after anesthesia
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia Morbidity
-
University of PecsCompleted
-
Cairo UniversityRecruiting
-
Universitätsklinikum Hamburg-EppendorfRecruitingAnesthesia Morbidity | Neurological Morbidity | Surgical ComplicationGermany
-
Cairo UniversityCompletedAnesthesia MorbidityEgypt
-
University of Maryland, BaltimoreAnesthesia Patient Safety FoundationCompleted
-
Dokuz Eylul UniversityEnrolling by invitationAnesthesia | Airway MorbiditySpain, Turkey
-
Namik Kemal UniversityCompletedRegional Anesthesia MorbidityTurkey
-
Mater Misericordiae University HospitalCompletedRegional Anesthesia MorbidityIreland
-
Seoul National University HospitalUnknownRegional Anesthesia MorbidityKorea, Republic of
Clinical Trials on Anesthesia
-
Ottawa Hospital Research InstituteCompleted
-
Nanjing Medical UniversityCompletedCesarean Section | Restless Leg SyndromeChina
-
Heidelberg UniversityCompletedAnesthesia Complication | Immune Suppression
-
Boston Children's HospitalFood and Drug Administration (FDA); Royal Children's Hospital; Murdoch Childrens... and other collaboratorsCompletedInguinal HerniaUnited States, Canada, Australia, Italy, United Kingdom, Netherlands, New Zealand
-
Universidade Estadual de Ponta GrossaCompletedLocal Anesthesia | Pain Management | Pediatric DentistryBrazil
-
Ohio State University Comprehensive Cancer CenterRecruitingPancreatic AdenocarcinomaUnited States
-
Second Affiliated Hospital of Xi'an Jiaotong UniversityUnknown
-
Peking University First HospitalPeking University; Peking University People's Hospital; Peking University Third... and other collaboratorsCompletedElderly | Long-term Outcome | Malignant Tumor | Epidural Anesthesia | Surgical ResectionChina
-
Ospedale degli Infermi di BiellaRecruiting
-
Medical University of LublinKonskie Specjalist HospitalCompletedPostoperative Pain | Pain, Acute | Mobility Limitation | Knee ArthropathyPoland