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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Belgium1 site
  • Antwerp University Hospital

    Edegem, Antwerp, 2650

Other trials in Belgium

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.

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 groups in NCT05308108
Study groupRoleWhat they receive
Children with Obstructive SleepapneaNot described
Receives: Procedure: (Adeno)tonsillectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of PORC related to age in children with/without comorbidities undergoing (adeno)tonsillectomy

    Number of PORC

    Measured: 24hr postoperative period

  2. 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)
  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.

  1. First posted1 Apr 2022
  2. Study start2 May 2022
  3. Primary completion7 Jan 2026
  4. Study completion7 Jan 2026

Resources

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
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

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.

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