Clinical trial NCT05532228: Evaluation of the Functional Impact of Adenotonsilectomy
Official title: Evaluation of the Functional Impact of Adenotonsilectomy in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apnea, Obstructive
Tonsillitis
Tonsillar Hypertrophy
Respiratory Function Impaired
Infections
ENT Disorder
Keywords: adenotonsillectomy
children
spirometry
obstructive sleep apnea
adenotonsillar hypertrophy
respiratory function
Lead sponsor: Instituto de Ciências Biomédicas Abel Salazar
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 78
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery within the scope of Pediatric Otorhinolaryngology at CHUPorto.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Forced expiratory volume in the first second (FEV 1)
timeFrame: 3 months after surgery
measure: Forced vital capacity (FVC)
timeFrame: 3 months after surgery
measure: Peak expiratory flow (PEF)
timeFrame: 3 months after surgery
measure: forced expiratory flow rate at 25% (F25)
timeFrame: 3 months after surgery
measure: forced expiratory flow rate at 75% (F75)
timeFrame: 3 months after surgery
measure: forced expiratory flow between 25 and 75% of the pulmonary volume (FEF25-75%).
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Weight
timeFrame: 3 months after surgery
measure: Diastolic arterial pressure
timeFrame: 3 months after surgery
measure: Systolic arterial pressure
timeFrame: 3 months after surgery
measure: Heart rate
timeFrame: 3 months after surgery
measure: rest oxygen saturation
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Univrsitário do Porto
Study officials:
References: