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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | 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 | Experimental | 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%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow nasal cannula | Other | 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%). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Klotz, M.D. | Center for Pediatrics, Dep. of Pediatric Intensive Care, Medical Center - University of Freiburg, Freiburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Pediatrics, Pediatric Intensive Care Unit, Procedure Room, Medical Center - University of Freiburg | Freiburg im Breisgau | 79100 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16978741 | Background | 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. | |
| 21680059 | Background |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D001049 | Apnea |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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|
| Standard respiratory care | Other | Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol. |
|
| 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 |
| 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |