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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obstructive sleep apnea | children with adenotonsillar hypertrophy and reports of nocturnal arousals/gasp/respiratory abnormalities |
| |
| No obstructive sleep apnea | children without adenotonsillar hypertrophy and no reports of nocturnal arousals/gasp/respiratory abnormalities |
| |
| Recurrent infections | Children with recurrent upper respiratory infections |
| |
| no recurrent infections | Children without recurrent upper respiratory infections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenotonsillectomy | Procedure | adenotonsillectomy by cold dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Diastolic arterial pressure |
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Inclusion Criteria:
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.
Exclusion Criteria:
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).
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Patients undergoing surgery within the scope of Pediatric Otorhinolaryngology at CHUPorto.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Univrsitário do Porto | Porto | 4099-001 | Portugal |
The investigators do not plan to share individual participant data
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D014069 | Tonsillitis |
| D012131 | Respiratory Insufficiency |
| D007239 | Infections |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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 |
| 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 |
| 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 |
| 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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |