NCT05532228

Brief Summary

Spirometric assessment of respiratory function before and after adenotonsillectomy surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

July 14, 2022

Last Update Submit

September 4, 2022

Conditions

Apnea, ObstructiveTonsillitisTonsillar HypertrophyRespiratory Function ImpairedInfectionsENT Disorder

Keywords

adenotonsillectomychildrenspirometryobstructive sleep apneaadenotonsillar hypertrophyrespiratory function

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • Weight

    3 months after surgery

  • Diastolic arterial pressure

    3 months after surgery

  • Systolic arterial pressure

    3 months after surgery

  • Heart rate

    3 months after surgery

  • rest oxygen saturation

    3 months after surgery

Study Arms (4)

Obstructive sleep apnea

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

Procedure: Adenotonsillectomy

No obstructive sleep apnea

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

Procedure: Adenotonsillectomy

Recurrent infections

Children with recurrent upper respiratory infections

Procedure: Adenotonsillectomy

no recurrent infections

Children without recurrent upper respiratory infections

Procedure: Adenotonsillectomy

Interventions

AdenotonsillectomyPROCEDURE

adenotonsillectomy by cold dissection

No obstructive sleep apneaObstructive sleep apneaRecurrent infectionsno recurrent infections

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Univrsitário do Porto

Porto, 4099-001, Portugal

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveTonsillitisRespiratory InsufficiencyInfectionsRespiratory Aspiration

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPharyngitisRespiratory Tract InfectionsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

September 8, 2022

Study Start

August 20, 2020

Primary Completion

December 1, 2021

Study Completion

February 1, 2022

Last Updated

September 8, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

The investigators do not plan to share individual participant data

Locations

PT(1)