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

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ClinicalTrials.gov Identifier: NCT02930525
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel Klotz, University of Freiburg

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).

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Other: High flow nasal cannula Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation: A Randomized Controlled Pilot Trial
Study Start Date : September 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
No Intervention: 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.
Experimental: High flow nasal cannula
High flow nasal cannula with ambient air and flow rates adapted to body weight as defined per protocol. Increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.
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%).




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930525


Contacts
Contact: Daniel Klotz, M.D. +4976127044510 daniel.klotz@uniklinik-freiburg.de

Locations
Germany
Center for Pediatrics, Pediatric Intensive Care Unit, Procedure Room, Medical Center - University of Freiburg Recruiting
Freiburg, Germany, 79100
Contact: Daniel Klotz, M.D.    +4976144510    daniel.klotz@uniklinik-freiburg.de   
Sub-Investigator: Hans Fuchs, M.D.         
Sponsors and Collaborators
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:
Responsible Party: Daniel Klotz, M.D., University of Freiburg
ClinicalTrials.gov Identifier: NCT02930525     History of Changes
Other Study ID Numbers: 143/16
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniel Klotz, University of Freiburg:
apnea
children
hypercarbia
procedural sedation
HFNC

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases