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

NCT02930525 | Completed

• 1 other identifier: 143/16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Insufficiency

Keywords

apnea; children; hypercarbia; procedural sedation; HFNC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Duration of respiratory instability

  Time frame from first applications of intravenous sedatives until finishing the intended procedure

• Number of interventions to regain respiratory stability

  Time frame from first applications of intravenous sedatives until finishing the intended procedure

• Need for noninvasive ventilation

  Time frame from first applications of intravenous sedatives until finishing the intended procedure

• 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 frame from first applications of intravenous sedatives until finishing the intended procedure

Study Arms (2)

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.

Other: Standard respiratory care

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%).

Other: High Flow nasal cannula

Interventions

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%).

High Flow nasal cannula

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.

Standard care

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 6 years - 18 years
• Undergoing pediatric non-emergency upper gastrointestinal endoscopy under sedation
• Informed consent/assent for enrollment by parents/legal guardians/patient

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Freiburg: lead

Study Sites (1)

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

Freiburg im Breisgau, 79100, Germany

Location

Related Publications (2)

• 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.

  PMID: 16978741 BACKGROUND

• 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.

  PMID: 21680059 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Apnea; Hypercapnia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Klotz, M.D.

  Center for Pediatrics, Dep. of Pediatric Intensive Care, Medical Center - University of Freiburg, Freiburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 9, 2016
• First Posted: October 12, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 19, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)