Respiratory InsufficiencyHiFiPPSNCT02930525
Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation
A study testing High Flow nasal cannula and Standard respiratory care in people with Respiratory Insufficiency, run by University of Freiburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- High Flow nasal cannula and Standard respiratory care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to 19 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6 years - 18 years
- Undergoing pediatric non-emergency upper gastrointestinal endoscopy under sedation
- Informed consent/assent for enrollment by parents/legal guardians/patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center for Pediatrics, Pediatric Intensive Care Unit, Procedure Room, Medical Center - University of Freiburg
Freiburg im Breisgau, 79100
About this study
Official title: 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).
- Conditions
- Respiratory Insufficiency
- Being tested
- High Flow nasal cannula, Standard respiratory care
- Keywords
- apnea, children, hypercarbia, procedural sedation, HFNC
- Medical subject headings
- Respiratory Insufficiency, Apnea, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow nasal cannulaOther
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 careOther
Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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%). Receives: Other: High Flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Secondary outcomes (8)
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)
Measured: 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)
Measured: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Need for noninvasive ventilation
Number of episodes of bag-mask-ventilation
Measured: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Time of procedure in minutes
Time of procedure in minutes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours after procedural sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Klotz, University of Freiburg
- Investigators
- Daniel Klotz, M.D., Principal investigator, Center for Pediatrics, Dep. of Pediatric Intensive Care, Medical Center - University of Freiburg, Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930525
- Sponsor's protocol ID
- 143/16
- Acronym
- HiFiPPS
- Status last verified
- Jul 2018
- First submitted
- 9 Oct 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 16978741Deitch 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.
PubMed 21680059
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT02930525
- Acronym / sponsor ID
- HiFiPPS / 143/16
- Conditions
- Respiratory Insufficiency
- Keywords
- apnea, children, hypercarbia, procedural sedation, HFNC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Standard respiratory careStandard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol. |
| High Flow nasal cannula | Experimental | Other: High Flow nasal cannulaApplication 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%). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 6 years - 18 years
- Undergoing pediatric non-emergency upper gastrointestinal endoscopy under sedation
- Informed consent/assent for enrollment by parents/legal guardians/patient
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow nasal cannulaApplication 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 |
| Standard respiratory careStandard 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 care |
Primary outcome
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)
8 secondary outcomes
Duration of respiratory instability
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Number of interventions to regain respiratory stability
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Need for noninvasive ventilation
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
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 sedation in minutes
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Use of sedatives
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Use of analgesics
Time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Nausea and vomiting
Time frame: 24 hours after procedural sedation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Background: PubMed 16978741Deitch 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.
- Background: PubMed 21680059Deitch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Klotz, M.D. principal investigator
Center for Pediatrics, Dep. of Pediatric Intensive Care, Medical Center - University of Freiburg, Freiburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow nasal cannula and Standard respiratory care in people with Respiratory Insufficiency, run by University of Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory instability (time frame: Time frame from first applications of intravenous sedatives until finishing the intended procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02930525, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.