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

Respiratory Insufficiency Clinical Trial

— HiFiPPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930525
• Other study ID #: 143/16
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 19, 2017

Study information

• Verified date: July 2018
• Source: University of Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 19, 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Other:
• 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%).
• 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.

Locations

Country	Name	City	State
Germany	Center for Pediatrics, Pediatric Intensive Care Unit, Procedure Room, Medical Center - University of Freiburg	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. Epub 2006 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Need for noninvasive ventilation	Number of episodes of bag-mask-ventilation	Time frame from first applications of intravenous sedatives until finishing the intended procedure
Secondary	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
Secondary	Time of sedation in minutes	Time of sedation in minutes	Time frame from first applications of intravenous sedatives until finishing the intended procedure
Secondary	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
Secondary	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
Secondary	Nausea and vomiting	Number of Episodes with nausea and/or vomiting within 24 hours after procedural sedation	24 hours after procedural sedation