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

Not Applicable

Completed

• Conditions: Respiratory Insufficiency
• Interventions: Other: Standard respiratory care; Other: High Flow nasal cannula

• Registration Number: NCT02930525
• Lead Sponsor: University of Freiburg

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-09
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-12
• Primary Completion: 2017-12
• Study Completion: 2017-12-19
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard respiratory care	Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.
High Flow nasal cannula	High Flow nasal cannula	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%).

Primary Outcome Measures

Name	Time	Method
Respiratory instability	Time frame from first applications of intravenous sedatives until finishing the intended procedure	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)

Secondary Outcome Measures

Name	Time	Method
Number of interventions to regain respiratory stability	Time frame from first applications of intravenous sedatives until finishing the intended procedure	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)
Duration of respiratory instability	Time frame from first applications of intravenous sedatives until finishing the intended procedure	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)
Need for noninvasive ventilation	Time frame from first applications of intravenous sedatives until finishing the intended procedure	Number of episodes of bag-mask-ventilation
Use of sedatives	Time frame from first applications of intravenous sedatives until finishing the intended procedure	Cumulative dose of i.v. sedatives in mg/kg bodyweight/min of procedure
Use of analgesics	Time frame from first applications of intravenous sedatives until finishing the intended procedure	Cumulative dose of i.v. analgesics in µg/kg bodyweight/min of procedure
Time of procedure in minutes	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 procedure in minutes
Time of sedation in minutes	Time frame from first applications of intravenous sedatives until finishing the intended procedure	Time of sedation in minutes
Nausea and vomiting	24 hours after procedural sedation	Number of Episodes with nausea and/or vomiting within 24 hours after procedural sedation

Trial Locations

Locations (1)

Center for Pediatrics, Pediatric Intensive Care Unit, Procedure Room, Medical Center - University of Freiburg; 🇩🇪 Freiburg, Germany