Respiratory Insufficiency
Conditions
Keywords
apnea, children, hypercarbia, procedural sedation, HFNC
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).
Interventions
OTHERHigh 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%).
Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.
Sponsors
University of Freiburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Need for noninvasive ventilation | Time frame from first applications of intravenous sedatives until finishing the intended procedure | Number of episodes of bag-mask-ventilation |
| 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 |
| 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) |
| 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 |
| Nausea and vomiting | 24 hours after procedural sedation | Number of Episodes with nausea and/or vomiting within 24 hours after procedural sedation |
| Time of sedation in minutes | Time frame from first applications of intravenous sedatives until finishing the intended procedure | Time of sedation in minutes |
Countries
Germany
Outcome results
None listed