Evaluation of the Functional Impact of Adenotonsilectomy

Instituto de Ciências Biomédicas Abel Salazar

Status: Completed

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

Treatments: Procedure: Adenotonsillectomy

Study type: Observational

Funder types: Other

Identifiers

NCT05532228

2020.176(137-DEFI/139-CE)

Details and patient eligibility

About

Spirometric assessment of respiratory function before and after adenotonsillectomy surgery

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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).

Trial design

78 participants in 4 patient groups

Obstructive sleep apnea

Description:

children with adenotonsillar hypertrophy and reports of nocturnal arousals/gasp/respiratory abnormalities

Treatment:

Procedure: Adenotonsillectomy

No obstructive sleep apnea

Description:

children without adenotonsillar hypertrophy and no reports of nocturnal arousals/gasp/respiratory abnormalities

Treatment:

Procedure: Adenotonsillectomy

Recurrent infections

Description:

Children with recurrent upper respiratory infections

Treatment:

Procedure: Adenotonsillectomy

no recurrent infections

Description:

Children without recurrent upper respiratory infections

Treatment:

Procedure: Adenotonsillectomy