Clinical trial NCT02930525: Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation
Official title: Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: apnea
children
hypercarbia
procedural sedation
HFNC
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Procedural sedation is an established and safe intervention and is widely used in diagnostic and therapeutic procedures for pediatric patients. Nonetheless, problems of the respiratory system such as upper airway obstruction, hypoventilation and apnea are frequent adverse events. We postulate that respiratory instability is less frequent in patients high flow nasal cannula vs. standard care on respiratory stability, i.e. low flow nasal cannula, in pediatric procedural sedation. The purpose of this pilot study is to estimate the effect of HFNC (high flow nasal cannula) on the respiratory instability in children undergoing upper gastrointestinal endoscopy under pediatric procedural sedation (PPS).


Eligibility 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

Primary outcomes:
measure: Respiratory instability
timeFrame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Secondary outcomes:
measure: Duration of respiratory instability
timeFrame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
measure: Number of interventions to regain respiratory stability
timeFrame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
measure: Need for noninvasive ventilation
timeFrame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
measure: Time of procedure in minutes
timeFrame: 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
measure: Time of sedation in minutes
timeFrame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
measure: Use of sedatives
timeFrame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
measure: Use of analgesics
timeFrame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
measure: Nausea and vomiting
timeFrame: 24 hours after procedural sedation
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Center for Pediatrics, Pediatric Intensive Care Unit, Procedure Room, Medical Center - University of Freiburg
Study officials:
affiliation: Center for Pediatrics, Dep. of Pediatric Intensive Care, Medical Center - University of Freiburg, Freiburg, Germany
name: Daniel Klotz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deitch K, Chudnofsky CR, Dominici P. The utility of supplemental oxygen during emergency department procedural sedation and analgesia with midazolam and fentanyl: a randomized, controlled trial. Ann Emerg Med. 2007 Jan;49(1):1-8. doi: 10.1016/j.annemergmed.2006.06.013. Epub 2006 Sep 15.
citation: Deitch K, Chudnofsky CR, Dominici P, Latta D, Salamanca Y. The utility of high-flow oxygen during emergency department procedural sedation and analgesia with propofol: a randomized, controlled trial. Ann Emerg Med. 2011 Oct;58(4):360-364.e3. doi: 10.1016/j.annemergmed.2011.05.018. Epub 2011 Jun 15.