Evaluation of the Functional Impact of Adenotonsilectomy

Evaluation of the Functional Impact of Adenotonsilectomy in Children

Spirometric assessment of respiratory function before and after adenotonsillectomy surgery

Study Overview

• Status: Completed
• Conditions: Infections; Tonsillitis; Apnea, Obstructive; Tonsillar Hypertrophy; Respiratory Function Impaired; ENT Disorder
• Intervention / Treatment: Procedure: Adenotonsillectomy

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 Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Univrsitário do Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery within the scope of Pediatric Otorhinolaryngology at CHUPorto.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obstructive sleep apnea; children with adenotonsillar hypertrophy and reports of nocturnal arousals/gasp/respiratory abnormalities	Procedure: Adenotonsillectomy; adenotonsillectomy by cold dissection
No obstructive sleep apnea; children without adenotonsillar hypertrophy and no reports of nocturnal arousals/gasp/respiratory abnormalities	Procedure: Adenotonsillectomy; adenotonsillectomy by cold dissection
Recurrent infections; Children with recurrent upper respiratory infections	Procedure: Adenotonsillectomy; adenotonsillectomy by cold dissection
no recurrent infections; Children without recurrent upper respiratory infections	Procedure: Adenotonsillectomy; adenotonsillectomy by cold dissection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto de Ciências Biomédicas Abel Salazar

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: September 4, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: adenotonsillar hypertrophy; children; obstructive sleep apnea; spirometry; adenotonsillectomy; respiratory function
• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Sleep Apnea Syndromes; Pharyngitis; Sleep Apnea, Obstructive; Respiratory Insufficiency; Hypertrophy; Tonsillitis
• Other Study ID Numbers: 2020.176(137-DEFI/139-CE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The investigators do not plan to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No