Skip to main content
OpenTrials
Completed

NCT Number: NCT02930525

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Insufficiency Apnea Hypercapnia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Freiburg im Breisgau, 79100, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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%).

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.

Primary outcomes

  1. Respiratory instability

    Time frame: 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 outcomes

  1. Duration of respiratory instability

    Time frame: 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)

  2. Number of interventions to regain respiratory stability

    Time frame: 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)

  3. Need for noninvasive ventilation

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

    Number of episodes of bag-mask-ventilation

  4. Time of procedure in minutes

    Time frame: 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

  5. Time of sedation in minutes

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

    Time of sedation in minutes

  6. Use of sedatives

    Time frame: 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

  7. Use of analgesics

    Time frame: 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

  8. Nausea and vomiting

    Time frame: 24 hours after procedural sedation

    Number of Episodes with nausea and/or vomiting within 24 hours after procedural sedation

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

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

Acronym: HiFiPPS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 12, 2016
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.