Obstructive Sleep ApneaPORCNCT05308108
Study of Postoperative Respiratory Complications in Children With Obstructive Sleep Apnea (PORC)
An observational study of Obstructive Sleep Apnea and Child, Only, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Adenotonsillectomy is the first line surgical treatment for children with Obstructive Sleep apnea Syndrome (OSAS). Postoperative respiratory complications (PORC) may occur and are often related to co-morbidities. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea, Child, Only, Surgery
- What is being tested?
- (Adeno)tonsillectomy
- Type of treatment
- Surgery or procedure
- How many people
- 132 participants
- Where
- 1 siteBelgium
- Study dates
- 2 May 2022to 7 Jan 2026
- How long will I take part?
- 1 Day
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with or without co-morbidities undergoing (adeno)tonsillectomy for OSAS during time frame of the study period
Who may be able to join
- scheduled for (adeno)tonsillectomy as treatment for OSAS
Who cannot join
- other surgery than (adeno)tonsillectomy performed as treatment for OSAS
- Polysomnography not available within 1 year before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Postoperative Respiratory Complications in Children With Obstructive Sleep Apnea.
Adenotonsillectomy is the first line surgical treatment for children with Obstructive Sleep apnea Syndrome (OSAS). Postoperative respiratory complications (PORC) may occur and are often related to co-morbidities. Despite guidelines from different scientific groups, there is no consensus on the monitoring requirements and management of PORC in these children.
Read the detailed description
Postoperative respiratory complications (PORC) may occur in children with obstructive sleep apnea undergoing upper airway surgery. The incidence of these postoperative respiratory complications can be affected by co-morbidities such as obesity, Down-syndrome, neurologic conditions, craniofacial malformation. Despite treatment guidelines from different scientific groups such as 'American Academy of Pediatrics', the 'European Respiratory Society' , the American Academy of Otorhinolaryngology and the American society of Anesthesiology, there is no consensus on the monitoring requirements and management of PORC in these children.
Further studies are required to investigate the role of age and OSAS severity on the occurence of PORC. Secondly, it would be interesting to develop a flowchart for the postoperative management of children with OSAS undergoing upper airway surgery, taking into account child-related factors such as age, OSAS and comorbidity.
As standard of care, all children are seen at the preoperative outpatient clinic by an anesthesiologist. If necessary, additional tests are performed with respect to the health condition of the child.
If all inclusion criteria are fulfilled and there are no exclusion criteria, Informed Consent will be asked of the accompanying parent or legal guardian.
Premedication is typically not indicated by these interventions because they are of short duration. In exceptional situations (for example an extremely anxious child) the use of premedication can be considered. In such a case, one can choose either midazolam sirup (Ozalin 0.25milligrams/kilogram (mg/kg) for children, 1 year or older, with a body weight of 3 to 40 kg) or Lorazepam sublingually (Temesta expidet) from an age of 6 years, dosage 0.5 mg for body weight of 25-50kg and dosage of 1 mg for body weight of 50 kg and more).
Per-operative anesthetic management: basic monitoring includes Electrocardiogram, non-invasive blood pressure monitoring, pulse oximetry, end-tidal carbon dioxide (EtCO2) and body temperature, intravenous (IV) access with administration of IV fluids as per body weight as standard of care. At the start of the intervention, venous access is obtained during inhalational anesthesia.
Drug-induced sleep endoscopy (DISE) is performed with IV propofol and/or sevoflurane. Induction of anesthesia occurs with IV propofol or inhalational anesthesia with sevoflurane. If propofol IV is used, a bolus of 10-20 mg and continuous infusion 6-10 mg/kg/hr is administered.
After the DISE examination, the child is intubated with fentanyl 2 micrograms/kg or sufentanil 0.2 micrograms/kg according to the clinical presentation. For neuromuscular block, atracurium 0.2 to 0.3 mg per kg is used. For maintenance of anesthesia a minimum alveolar concentration (MAC) 1 to 1.5 sevoflurane is kept.
Postoperative pain management is achieved by a combination of analgesics (non-steroidal anti-inflammatory drugs and paracetamol) as per age-specific indications (IV paracetamol 20mg/kg, ketorolac 0.5 mg/kg and morfine 0.05 mg/kg in cases of tonsillectomy) Postoperative nausea and vomiting is prevented by a single shot dexamethasone 0.15 milligram/kilogram IV.
After surgery, when the patient is awake he or she will be extubated and transferred to the Post Anesthetic Care Unit (PACU or recovery room) for monitoring of vital signs. Minimal requirement in the recovery room is a peripheral saturation monitor.
Monitoring of postoperative respiratory complications starts at end of surgery. So if a child develops respiratory problems upon awakening from anesthesia but before admission to the recovery room, these will also be registered as postoperative respiratory complications. Possible PORC are: laryngospasm, bronchospasm, desaturation requiring Oxygen, pulmonary edema.
In case of occurrence of PORC, the following interventions will be applied per protocol:
- oxygen saturation level between 92-95%: adopt lateral position
- oxygen saturation below 92% : administer oxygen (O2) via nasal prongs 1 Liter/ Minute (L/M)
- monitoring pulse oximetry for 2 minutes;
- in case of no response, increase O2 therapy via nasal prongs to 1.5 L/M
- monitoring pulse oximetry for 2 minutes;
- in case of no response, O2 therapy via nasal prongs will be increased to 2 L/M
- monitoring pulse oximetry for 2 minutes
- in case of no response, increase O2 therapy via nasal prongs to 2.5 L/M
- monitoring pulse oximetry for 2 minutes
- in case of no response, increase O2 therapy via nasal prongs to 3 L/M
- monitoring pulse oximetry for 2 minutes
- in case of no response, increase O2 therapy via nasal prongs to 3.5 L/M
- monitoring pulse oximetry for 2 minutes
- in case of no response, increase O2 therapy via nasal prongs to 4 L/M
- If pulse oximetry stays below 92 % despite standard O2 therapy at 4 L/M, nasal high flow therapy (Optiflow) will be applied according to the bodyweight.
- Flow = 2 l/kg/min with fraction of inspired oxygen (FiO2) 50% for bodyweight up to 10kg. If bodyweight > 10 kg add 0.5 l/kg/min extra
- monitor for 2 minutes
- If no improvement, Optiflow with FIO2 80%
- In case of persistent low pulse oximetry (below 92%) and no improvement of clinical symptoms, patient will be intubated and transferred to the Pediatric Intensive Care Unit (PICU)
- Postoperative pain management during first 24H after surgery: Paracetamol 15 mg/kg 4 times a day and Taradyl 0.5 mg/kg 3 times/day
- PORC will be registered every 30 minutes the first 6H postoperative. Upon arrival at the ward, PORC will be registered for 24 hours.
- All patients stay at least one night in hospital for overnight pulse oximetry monitoring
When the clinical parameters are stable for 30 minutes, at any time of the study protocol, the registration period for the study ends. Further management according to the responsible physician.
- Conditions
- Obstructive Sleep Apnea, Child, Only, Surgery
- Being tested
- (Adeno)tonsillectomy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Adeno)tonsillectomyProcedure or surgery
registration of PORC in children with OSAS after (adeno)tonsillectomy
| Study group | Role | What they receive |
|---|---|---|
| Children with Obstructive Sleepapnea | Not described Receives: Procedure: (Adeno)tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PORC related to age in children with/without comorbidities undergoing (adeno)tonsillectomy
Number of PORC
Measured: 24hr postoperative period
The incidence of PORC related to OSAS severity in children with/without comorbidities undergoing (adeno)tonsillectomy
Number of PORC
Measured: 24 hr postoperative period
Secondary outcomes (1)
Development of a flow chart for postoperative monitoring of PORC in children with OSA
Flowchart
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start2 May 2022
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- 132 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vera Saldien, University Hospital, Antwerp
- Investigators
- Vera Saldien, MD,PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308108
- Sponsor's protocol ID
- 002364
- Acronym
- PORC
- Status last verified
- Jan 2026
- First submitted
- 24 Mar 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Postoperative Respiratory Complications in Children With Obstructive Sleep Apnea.
- ClinicalTrials.gov ID
- NCT05308108
- Acronym / sponsor ID
- PORC / 002364
- Conditions
- Obstructive Sleep Apnea, Child, Only, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 1 Apr 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.
Adenotonsillectomy is the first line surgical treatment for children with Obstructive Sleep apnea Syndrome (OSAS). Postoperative respiratory complications (PORC) may occur and are often related to co-morbidities. Despite guidelines from different scientific groups, there is no consensus on the monitoring requirements and management of PORC in these children.
Detailed description
Postoperative respiratory complications (PORC) may occur in children with obstructive sleep apnea undergoing upper airway surgery. The incidence of these postoperative respiratory complications can be affected by co-morbidities such as obesity, Down-syndrome, neurologic conditions, craniofacial malformation. Despite treatment guidelines from different scientific groups such as 'American Academy of Pediatrics', the 'European Respiratory Society' , the American Academy of Otorhinolaryngology and the American society of Anesthesiology, there is no consensus on the monitoring requirements and management of PORC in these children.
Further studies are required to investigate the role of age and OSAS severity on the occurence of PORC. Secondly, it would be interesting to develop a flowchart for the postoperative management of children with OSAS undergoing upper airway surgery, taking into account child-related factors such as age, OSAS and comorbidity.
As standard of care, all children are seen at the preoperative outpatient clinic by an anesthesiologist. If necessary, additional tests are performed with respect to the health condition of the child.
If all inclusion criteria are fulfilled and there are no exclusion criteria, Informed Consent will be asked of the accompanying parent or legal guardian.
Premedication is typically not indicated by these interventions because they are of short duration. In exceptional situations (for example an extremely anxious child) the use of premedication can be considered. In such a case, one can choose either midazolam sirup (Ozalin 0.25milligrams/kilogram (mg/kg) for children, 1 year or older, with a body weight of 3 to 40 kg) or Lorazepam sublingually (Temesta expidet) from an age of 6 years, dosage 0.5 mg for body weight of 25-50kg and dosage of 1 mg for body weight of 50 kg and more).
Per-operative anesthetic management: basic monitoring includes Electrocardiogram, non-invasive blood pressure monitoring, pulse oximetry, end-tidal carbon dioxide (EtCO2) and body temperature, intravenous (IV) access with administration of IV fluids as per body weight as standard of care. At the start of the intervention, venous access is obtained during inhalational anesthesia.
Drug-induced sleep endoscopy (DISE) is performed with IV propofol and/or sevoflurane. Induction of anesthesia occurs with IV propofol or inhalational anesthesia with sevoflurane. If propofol IV is used, a bolus of 10-20 mg and continuous infusion 6-10 mg/kg/hr is administered.
After the DISE examination, the child is intubated with fentanyl 2 micrograms/kg or sufentanil 0.2 micrograms/kg according to the clinical presentation. For neuromuscular block, atracurium 0.2 to 0.3 mg per kg is used. For maintenance of anesthesia a minimum alveolar concentration (MAC) 1 to 1.5 sevoflurane is kept.
Postoperative pain management is achieved by a combination of analgesics (non-steroidal anti-inflammatory drugs and paracetamol) as per age-specific indications (IV paracetamol 20mg/kg, ketorolac 0.5 mg/kg and morfine 0.05 mg/kg in cases of tonsillectomy) Postoperative nausea and vomiting is prevented by a single shot dexamethasone 0.15 milligram/kilogram IV.
After surgery, when the patient is awake he or she will be extubated and transferred to the Post Anesthetic Care Unit (PACU or recovery room) for monitoring of vital signs. Minimal requirement in the recovery room is a peripheral saturation monitor.
Monitoring of postoperative respiratory complications starts at end of surgery. So if a child develops respiratory problems upon awakening from anesthesia but before admission to the recovery room, these will also be registered as postoperative respiratory complications. Possible PORC are: laryngospasm, bronchospasm, desaturation requiring Oxygen, pulmonary edema.
In case of occurrence of PORC, the following interventions will be applied per protocol:
- oxygen saturation level between 92-95%: adopt lateral position
- oxygen saturation below 92% : administer oxygen (O2) via nasal prongs 1 Liter/ Minute (L/M)
- monitoring pulse oximetry for 2 minutes;
- in case of no response, increase O2 therapy via nasal prongs to 1.5 L/M
- monitoring pulse oximetry for 2 minutes;
- in case of no response, O2 therapy via nasal prongs will be increased to 2 L/M
- monitoring pulse oximetry for 2 minutes
- in case of no response, increase O2 therapy via nasal prongs to 2.5 L/M
- monitoring pulse oximetry for 2 minutes
- in case of no response, increase O2 therapy via nasal prongs to 3 L/M
- monitoring pulse oximetry for 2 minutes
- in case of no response, increase O2 therapy via nasal prongs to 3.5 L/M
- monitoring pulse oximetry for 2 minutes
- in case of no response, increase O2 therapy via nasal prongs to 4 L/M
- If pulse oximetry stays below 92 % despite standard O2 therapy at 4 L/M, nasal high flow therapy (Optiflow) will be applied according to the bodyweight.
- Flow = 2 l/kg/min with fraction of inspired oxygen (FiO2) 50% for bodyweight up to 10kg. If bodyweight > 10 kg add 0.5 l/kg/min extra
- monitor for 2 minutes
- If no improvement, Optiflow with FIO2 80%
- In case of persistent low pulse oximetry (below 92%) and no improvement of clinical symptoms, patient will be intubated and transferred to the Pediatric Intensive Care Unit (PICU)
- Postoperative pain management during first 24H after surgery: Paracetamol 15 mg/kg 4 times a day and Taradyl 0.5 mg/kg 3 times/day
- PORC will be registered every 30 minutes the first 6H postoperative. Upon arrival at the ward, PORC will be registered for 24 hours.
- All patients stay at least one night in hospital for overnight pulse oximetry monitoring
When the clinical parameters are stable for 30 minutes, at any time of the study protocol, the registration period for the study ends. Further management according to the responsible physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Obstructive Sleepapnea | – | Procedure: (Adeno)tonsillectomy |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with or without co-morbidities undergoing (adeno)tonsillectomy for OSAS during time frame of the study period
Key inclusion criteria (1 listed)
- scheduled for (adeno)tonsillectomy as treatment for OSAS
Key exclusion criteria (2 listed)
- other surgery than (adeno)tonsillectomy performed as treatment for OSAS
- Polysomnography not available within 1 year before surgery
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 |
|---|---|---|
| (Adeno)tonsillectomyregistration of PORC in children with OSAS after (adeno)tonsillectomy | Procedure or surgery | Children with Obstructive Sleepapnea |
Primary outcome
The incidence of PORC related to age in children with/without comorbidities undergoing (adeno)tonsillectomy
Time frame: 24hr postoperative period
Number of PORC
The incidence of PORC related to OSAS severity in children with/without comorbidities undergoing (adeno)tonsillectomy
Time frame: 24 hr postoperative period
Number of PORC
1 secondary outcome
Development of a flow chart for postoperative monitoring of PORC in children with OSA
Time frame: 2 years
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 27 Jan 2026.
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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.
Vera Saldien, MD,PhD principal investigator
University Hospital, Antwerp
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 Obstructive Sleep Apnea and Child, Only, run by University Hospital, Antwerp at 1 site in Belgium.
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 1 inclusion and 2 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 27 Jan 2026. 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 Belgium. 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?
The incidence of PORC related to age in children with/without comorbidities undergoing (adeno)tonsillectomy (time frame: 24hr postoperative period). The study lists 2 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 27 Jan 2026.