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Clinical Trials/NCT05308108
NCT05308108CompletedNot Applicable

Study of Postoperative Respiratory Complications in Children With Obstructive Sleep Apnea.

University Hospital, Antwerp1 site in 1 country132 target enrollmentStarted: May 2, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
132
Locations
1
Primary Endpoint
The incidence of PORC related to OSAS severity in children with/without comorbidities undergoing (adeno)tonsillectomy

Study Overview

Brief 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. 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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Year to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • scheduled for (adeno)tonsillectomy as treatment for OSAS

Exclusion Criteria

  • other surgery than (adeno)tonsillectomy performed as treatment for OSAS
  • Polysomnography not available within 1 year before surgery

Arms & Interventions

Children with Obstructive Sleepapnea

Intervention: (Adeno)tonsillectomy (Procedure)

Outcomes

Primary Outcomes

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

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

Time Frame: 24hr postoperative period

Number of PORC

Secondary Outcomes

  • Development of a flow chart for postoperative monitoring of PORC in children with OSA(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vera Saldien

Principle Investigator

University Hospital, Antwerp

Study Sites (1)

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