Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02930525
• Date of registration: 09/10/2016
• Prospective Registration: No
• Primary sponsor: University of Freiburg
• Public title: Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation HiFiPPS
• Scientific title: Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation: A Randomized Controlled Pilot Trial
• Date of first enrolment: September 2016
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02930525
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Daniel Klotz, M.D.
• Affiliation: Center for Pediatrics, Dep. of Pediatric Intensive Care, Medical Center - University of Freiburg, Freiburg, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 6 years - 18 years

2. Undergoing pediatric non-emergency upper gastrointestinal endoscopy under sedation

3. Informed consent/assent for enrollment by parents/legal guardians/patient

Exclusion Criteria:

1. Congenital or acquired malformations involving the airways

2. Patients with the history of spontaneous pneumothorax or connectives tissue diseases
(Marfan syndrome, Ehlers-Danlos-Syndrome)

3. Patients with a history of traumatic/iatrogenic air leak within the last 3 months
before enrollment



Age minimum: 6 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Insufficiency

Intervention(s)

Other: High Flow nasal cannula

Other: Standard respiratory care

Primary Outcome(s)

Respiratory instability [Time Frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure]

Secondary Outcome(s)

Time of sedation in minutes [Time Frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure]

Time of procedure in minutes [Time Frame: Duration of the procedure for which sedation is determined. It covers the time period from first positioning of the patient to repositioning of the patient or patients extremities after completion of the procedure]

Duration of respiratory instability [Time Frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure]

Nausea and vomiting [Time Frame: 24 hours after procedural sedation]

Number of interventions to regain respiratory stability [Time Frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure]

Use of analgesics [Time Frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure]

Use of sedatives [Time Frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure]

Need for noninvasive ventilation [Time Frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure]

Secondary ID(s)

143/16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors