Evaluation of the Functional Impact of Adenotonsilectomy

Study Overview
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Brief Summary
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Spirometric assessment of respiratory function before and after adenotonsillectomy surgery

Detailed Description
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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.

Official Title
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Evaluation of the Functional Impact of Adenotonsilectomy in Children

Conditions
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Apnea, Obstructive, Tonsillitis, Tonsillar Hypertrophy, Respiratory Function Impaired, Infections, ENT Disorder

Intervention / Treatment
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* Procedure: Adenotonsillectomy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obstructive sleep apnea<br>children with adenotonsillar hypertrophy and reports of nocturnal arousals/gasp/respiratory abnormalities | Procedure: Adenotonsillectomy<br>* adenotonsillectomy by cold dissection<br>|
| No obstructive sleep apnea<br>children without adenotonsillar hypertrophy and no reports of nocturnal arousals/gasp/respiratory abnormalities | Procedure: Adenotonsillectomy<br>* adenotonsillectomy by cold dissection<br>|
| Recurrent infections<br>Children with recurrent upper respiratory infections | Procedure: Adenotonsillectomy<br>* adenotonsillectomy by cold dissection<br>|
| no recurrent infections<br>Children without recurrent upper respiratory infections | Procedure: Adenotonsillectomy<br>* adenotonsillectomy by cold dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in the first second (FEV 1) | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. | 3 months after surgery | 
| Forced vital capacity (FVC) | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. | 3 months after surgery | 
| Peak expiratory flow (PEF) | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. | 3 months after surgery | 
| forced expiratory flow rate at 25% (F25) | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. | 3 months after surgery | 
| forced expiratory flow rate at 75% (F75) | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. | 3 months after surgery | 
| forced expiratory flow between 25 and 75% of the pulmonary volume (FEF25-75%). | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. | 3 months after surgery | 
| Diastolic arterial pressure | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. | 3 months after surgery | 
| Systolic arterial pressure | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. | 3 months after surgery | 
| Heart rate | Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery. | 3 months after surgery | 
| rest oxygen saturation | 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 | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenotonsillectomy, children, spirometry, obstructive sleep apnea, adenotonsillar hypertrophy, respiratory function