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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Application of humidified heated ambient air with flow rates adapted to body weight of respective subject. Incremental increase of fraction of inspired oxygen as appropriate to maintain oxygenation (defined as transcutaneous pulse oximetry above 93%).
Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.
Center for Pediatrics, Pediatric Intensive Care Unit, Procedure Room, Medical Center - University of Freiburg
Freiburg im Breisgau, Germany
Respiratory instability
Number of episodes longer than 15 seconds with SpO2 \< 93% and/ or pCO2 \> 45 mmHg and/ or apnea (defined as cessation of airflow for \> 15 seconds)
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Duration of respiratory instability
Total duration of episodes longer than 15 seconds with oxygenation as measured per pulse oximetry \< 93% and/or transcutaneously measured carbon dioxide partial pressure \> 45 mmHg and/ or apnea (defined as cessation of airflow for \> 15 seconds)
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Number of interventions to regain respiratory stability
Number of interventions to reestablish respiratory stability (combined numbers of episode for jaw thrust, repositioning of the patient, repositioning of the patients head, tactile stimulation)
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Need for noninvasive ventilation
Number of episodes of bag-mask-ventilation
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Time of procedure in minutes
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
Time of sedation in minutes
Time of sedation in minutes
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Use of sedatives
Cumulative dose of i.v. sedatives in mg/kg bodyweight/min of procedure
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Use of analgesics
Cumulative dose of i.v. analgesics in µg/kg bodyweight/min of procedure
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Nausea and vomiting
Number of Episodes with nausea and/or vomiting within 24 hours after procedural sedation
Time frame: 24 hours after procedural sedation
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