An observational study in Apnea, Obstructive, Tonsillitis and Tonsillar Hypertrophy, sponsored by Instituto de Ciências Biomédicas Abel Salazar. Completed at 1 site in Portugal. Open to participants aged 4 Years to 14 Years. Per ClinicalTrials.gov, last updated 2022-09-08.
Sponsored by Instituto de Ciências Biomédicas Abel Salazar · Observational
Spirometric assessment of respiratory function before and after adenotonsillectomy surgery
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 78 is below the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Instituto de Ciências Biomédicas Abel Salazar is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing surgery within the scope of Pediatric Otorhinolaryngology at CHUPorto.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with surgical indication for any combination of:
Exclusion Criteria:
associated co-morbidities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
children with adenotonsillar hypertrophy and reports of nocturnal arousals/gasp/respiratory abnormalities
Procedure: Adenotonsillectomy
children without adenotonsillar hypertrophy and no reports of nocturnal arousals/gasp/respiratory abnormalities
Procedure: Adenotonsillectomy
Children with recurrent upper respiratory infections
Procedure: Adenotonsillectomy
Children without recurrent upper respiratory infections
Procedure: Adenotonsillectomy
adenotonsillectomy by cold dissection
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after surgery
Weight
Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 3 months after surgery
Plan to share: No — The investigators do not plan to share individual participant data
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Instituto de Ciências Biomédicas Abel Salazar