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

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

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).

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Other: Standard respiratory care; Other: High Flow nasal cannula

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany, 79100
    • Center for Pediatrics, Pediatric Intensive Care Unit, Procedure Room, Medical Center - University of Freiburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard 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.	Other: 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.
Experimental: 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%).	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%).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Freiburg
• Investigators: Principal Investigator: Daniel Klotz, M.D., Center for Pediatrics, Dep. of Pediatric Intensive Care, Medical Center - University of Freiburg, Freiburg, Germany

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 19, 2017

Study Registration Dates

• First Submitted: October 9, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimate): October 12, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: apnea; children; HFNC; procedural sedation; hypercarbia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 143/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO