Evaluation of the Functional Impact of Adenotonsilectomy

Infections Clinical Trial

Official title:

Evaluation of the Functional Impact of Adenotonsilectomy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05532228
• Other study ID #: 2020.176(137-DEFI/139-CE)
• Status: Completed
• Start date: August 20, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: September 2022
• Source: Instituto de Ciências Biomédicas Abel Salazar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Spirometric assessment of respiratory function before and after adenotonsillectomy surgery

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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).

Related Conditions & MeSH terms

• Apnea, Obstructive
• ENT Disorder
• Hypertrophy
• Infections
• Respiratory Function Impaired
• Respiratory Insufficiency
• Sleep Apnea, Obstructive
• Tonsillar Hypertrophy
• Tonsillitis

Intervention

Procedure:
• Adenotonsillectomy
adenotonsillectomy by cold dissection

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Univrsitário do Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Ciências Biomédicas Abel Salazar

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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