Skip to main content
OpenTrials
Completed

NCT Number: NCT05532228

Evaluation of the Functional Impact of Adenotonsilectomy

Spirometric assessment of respiratory function before and after adenotonsillectomy surgery

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Adenotonsillectomy

Procedure

adenotonsillectomy by cold dissection

Primary outcomes

  1. Forced expiratory volume in the first second (FEV 1)

    Time frame: 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.

  2. Forced vital capacity (FVC)

    Time frame: 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.

  3. Peak expiratory flow (PEF)

    Time frame: 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.

  4. forced expiratory flow rate at 25% (F25)

    Time frame: 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.

  5. forced expiratory flow rate at 75% (F75)

    Time frame: 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.

  6. forced expiratory flow between 25 and 75% of the pulmonary volume (FEF25-75%).

    Time frame: 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 outcomes

  1. Weight

    Time frame: 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.

  2. Diastolic arterial pressure

    Time frame: 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.

  3. Systolic arterial pressure

    Time frame: 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.

  4. Heart rate

    Time frame: 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.

  5. rest oxygen saturation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Instituto de Ciências Biomédicas Abel Salazar

Other

Registry information

Official study title

Evaluation of the Functional Impact of Adenotonsilectomy in Children

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 8, 2022
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.