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

Study Overview
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Brief Summary
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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).

Official Title
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Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation: A Randomized Controlled Pilot Trial

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Other: High Flow nasal cannula
* Other: Standard respiratory care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 years - 18 years Undergoing pediatric non-emergency upper gastrointestinal endoscopy under sedation Informed consent/assent for enrollment by parents/legal guardians/patient Exclusion Criteria: Congenital or acquired malformations involving the airways Patients with the history of spontaneous pneumothorax or connectives tissue diseases (Marfan syndrome, Ehlers-Danlos-Syndrome) Patients with a history of traumatic/iatrogenic air leak within the last 3 months before enrollment

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol. | Other: Standard respiratory care<br>* Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.<br>|
| Experimental: High Flow nasal cannula<br>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%). | Other: High Flow nasal cannula<br>* 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%).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 from first applications of intravenous sedatives until finishing the intended procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 from first applications of intravenous sedatives until finishing the intended procedure | 
| Need for noninvasive ventilation | Number of episodes of bag-mask-ventilation | Time frame from first applications of intravenous sedatives until finishing the intended procedure | 
| Time of procedure in minutes | 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 sedation in minutes | Time of sedation in minutes | 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 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 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 | 24 hours after procedural sedation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apnea, children, hypercarbia, procedural sedation, HFNC