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Clinical Trials/NCT04852432
NCT04852432
Recruiting
N/A

Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients

Seoul National University Hospital1 site in 1 country258 target enrollmentJuly 27, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Sedation
Sponsor
Seoul National University Hospital
Enrollment
258
Locations
1
Primary Endpoint
Desaturation (≤95%)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The investigators evaluate the efficacy and safety of routine administration of oxygen during moderate or deep sedation in pediatric patients. In addition, in terms of efficacy and safety, oxygen administration via nasal prong and high flow nasal cannula will be compared.

Registry
clinicaltrials.gov
Start Date
July 27, 2021
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Children under the age of 18 who undergo moderate-deep sedation

Exclusion Criteria

  • Respiratory failure patients
  • Increased intracranial pressure
  • Recent massive nasal bleeding
  • History of airway surgery
  • Complete nasal obstruction
  • Pulmonary hypertension
  • Skull base fracture

Outcomes

Primary Outcomes

Desaturation (≤95%)

Time Frame: through study completion, average 30 minutes

Occurrence of desaturation (pulse oximeter ≤95%)

Secondary Outcomes

  • Desaturation (≤90%)(through study completion, average 30 minutes)
  • CO2 value(through study completion, average 30 minutes)
  • Minimum saturation during sedation(through study completion, average 30 minutes)
  • Complications(through study completion, average 30 minutes)

Study Sites (1)

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