Apnea, ObstructiveNCT05532228
Evaluation of the Functional Impact of Adenotonsilectomy
An observational study of Apnea, Obstructive and Tonsillitis, run by Instituto de Ciências Biomédicas Abel Salazar at 1 site in Portugal.
Trial summary
Spirometric assessment of respiratory function before and after adenotonsillectomy surgery Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Apnea, Obstructive, Tonsillitis, Tonsillar Hypertrophy
- What is being tested?
- Adenotonsillectomy
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Aug 2020to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients undergoing surgery within the scope of Pediatric Otorhinolaryngology at CHUPorto.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- cardiopulmonary disease
- patients without surgical indication
- other causes of nasal obstruction (severe septum deviation or polyps).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Functional Impact of Adenotonsilectomy in Children
Spirometric assessment of respiratory function before and after adenotonsillectomy surgery
Read the 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.
- Conditions
- Apnea, Obstructive, Tonsillitis, Tonsillar Hypertrophy, Respiratory Function Impaired, Infections, ENT Disorder
- Being tested
- Adenotonsillectomy
- Keywords
- adenotonsillectomy, children, spirometry, obstructive sleep apnea, adenotonsillar hypertrophy, respiratory function
- Medical subject headings
- Sleep Apnea, Obstructive, Tonsillitis, Respiratory Insufficiency, Infections, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenotonsillectomyProcedure or surgery
adenotonsillectomy by cold dissection
| Study group | Role | What they receive |
|---|---|---|
| Obstructive sleep apnea | children with adenotonsillar hypertrophy and reports of nocturnal arousals/gasp/respiratory abnormalities Receives: Procedure: Adenotonsillectomy | |
| No obstructive sleep apnea | children without adenotonsillar hypertrophy and no reports of nocturnal arousals/gasp/respiratory abnormalities Receives: Procedure: Adenotonsillectomy | |
| Recurrent infections | Children with recurrent upper respiratory infections Receives: Procedure: Adenotonsillectomy | |
| no recurrent infections | Children without recurrent upper respiratory infections Receives: Procedure: Adenotonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after surgery
Secondary outcomes (5)
Weight
Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start20 Aug 2020
- Primary completion1 Dec 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Ciências Biomédicas Abel Salazar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532228
- Sponsor's protocol ID
- 2020.176(137-DEFI/139-CE)
- Status last verified
- Sep 2022
- First submitted
- 14 Jul 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Functional Impact of Adenotonsilectomy in Children
- ClinicalTrials.gov ID
- NCT05532228
- Acronym / sponsor ID
- 2020.176(137-DEFI/139-CE)
- Conditions
- Apnea, Obstructive, Tonsillitis, Tonsillar Hypertrophy, Respiratory Function Impaired, Infections, ENT Disorder
- Keywords
- adenotonsillectomy, children, spirometry, obstructive sleep apnea, adenotonsillar hypertrophy, respiratory function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Instituto de Ciências Biomédicas Abel SalazarUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obstructive sleep apnea | – | Procedure: Adenotonsillectomychildren with adenotonsillar hypertrophy and reports of nocturnal arousals/gasp/respiratory abnormalities |
| No obstructive sleep apnea | – | Procedure: Adenotonsillectomychildren without adenotonsillar hypertrophy and no reports of nocturnal arousals/gasp/respiratory abnormalities |
| Recurrent infections | – | Procedure: AdenotonsillectomyChildren with recurrent upper respiratory infections |
| no recurrent infections | – | Procedure: AdenotonsillectomyChildren without recurrent upper respiratory infections |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients undergoing surgery within the scope of Pediatric Otorhinolaryngology at CHUPorto.
Key inclusion criteria (8 listed)
- Age between 4-14 years;
- Patients with surgical indication for any combination of:
- naive children (not submitted to previous ENT surgery);
- signature of informed consent by the parent entity.
Key exclusion criteria (9 listed)
- Age under 4 years and over 14 years;
- surgery: myringotomy+TT placement exclusively;
- associated co-morbidities:
- patients without surgical indication
- other causes of nasal obstruction (severe septum deviation or polyps).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenotonsillectomyadenotonsillectomy by cold dissection | Procedure or surgery | No obstructive sleep apnea, Obstructive sleep apnea, Recurrent infections, no recurrent infections |
Primary outcome
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Weight
Time frame: 3 months after surgery
Diastolic arterial pressure
Time frame: 3 months after surgery
Systolic arterial pressure
Time frame: 3 months after surgery
Heart rate
Time frame: 3 months after surgery
rest oxygen saturation
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No. The investigators do not plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, Obstructive and Tonsillitis, run by Instituto de Ciências Biomédicas Abel Salazar at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in the first second (FEV 1) (time frame: 3 months after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.