Apnea, Obstructive, ENT Disorder, Infections, Respiratory Function Impaired, Tonsillar Hypertrophy, Tonsillitis
Conditions
Keywords
adenotonsillectomy, children, spirometry, obstructive sleep apnea, adenotonsillar hypertrophy, respiratory function
Brief summary
Spirometric assessment of respiratory function before and after adenotonsillectomy surgery
Detailed description
Spirometric assessment of respiratory function before and after adenotonsillectomy surgery Study site at CHUPorto: Department of Otorhinolaryngology at CHUPorto, Portugal. Study design: Institutional, observational, cohort, prospective. Classification of studies according to the law of clinical investigation (Dec. Law No. 21/2014): Clinical study without intervention. Main objective of the study: To collect a database referring to pediatric patients enrolled for surgery in an outpatient setting, in order to compare vital, spirometric and clinical parameters at two different times: pre and post surgical intervention. Secondary objectives of the study: Based on validated indices, to assess the impact of surgical intervention on the child's respiratory and cardiovascular system. Participants: Patients undergoing surgery in the field of Pediatric Otorhinolaryngology at CHUPorto, a tertiary referral Hospital in Portugal.
Interventions
PROCEDUREAdenotonsillectomy
adenotonsillectomy by cold dissection
Sponsors
Instituto de Ciências Biomédicas Abel Salazar
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Age between 4-14 years; * Patients with surgical indication for any combination of: * tonsillectomy * adenoidectomy * turbinoplasty * myringotomy; * naive children (not submitted to previous ENT surgery); * signature of informed consent by the parent entity.
Exclusion criteria
* Age under 4 years and over 14 years; * surgery: myringotomy+TT placement exclusively; * associated co-morbidities: * asthma/other obstructive lung diseases * congenital facial or thoracic dysmorphism * neurological disease with cognitive impairment * cardiopulmonary disease * patients without surgical indication * other causes of nasal obstruction (severe septum deviation or polyps).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| forced expiratory flow between 25 and 75% of the pulmonary volume (FEF25-75%). | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. |
| Forced expiratory volume in the first second (FEV 1) | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. |
| Forced vital capacity (FVC) | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. |
| Peak expiratory flow (PEF) | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. |
| forced expiratory flow rate at 25% (F25) | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. |
| forced expiratory flow rate at 75% (F75) | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic arterial pressure | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. |
| Systolic arterial pressure | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. |
| Heart rate | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. |
| rest oxygen saturation | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. (through instant photoplethysmography in the index finger with the patient in a calm environment |
| Weight | 3 months after surgery | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. |
Countries
Portugal
Outcome results
None listed