Evaluation of the Functional Impact of Adenotonsilectomy

Completed

• Conditions: Infections; Respiratory Function Impaired; ENT Disorder; Apnea, Obstructive; Tonsillitis; Tonsillar Hypertrophy
• Interventions: Procedure: Adenotonsillectomy

• Registration Number: NCT05532228
• Lead Sponsor: Instituto de Ciências Biomédicas Abel Salazar

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.

Study Timeline

• Study Start: 2020-08-20
• Primary Completion: 2021-12-01
• Study Completion: 2022-02-01
• Study First Submitted: 2022-07-14
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-04
• Last Update Submitted: 2022-09-04
• Study First Posted: 2022-09-08
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obstructive sleep apnea	Adenotonsillectomy	children with adenotonsillar hypertrophy and reports of nocturnal arousals/gasp/respiratory abnormalities
No obstructive sleep apnea	Adenotonsillectomy	children without adenotonsillar hypertrophy and no reports of nocturnal arousals/gasp/respiratory abnormalities
Recurrent infections	Adenotonsillectomy	Children with recurrent upper respiratory infections
no recurrent infections	Adenotonsillectomy	Children without recurrent upper respiratory infections

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Centro Hospitalar Univrsitário do Porto; 🇵🇹 Porto, Portugal