Respiratory DiseaseNCT03976167
Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy
A study testing Oxygen administration with Common nasal cannula and Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel in people with Respiratory Disease, run by Hospital Son Espases.
Trial summary
Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. Read more about this study
- Who is it for?
- Ages 29 days to 16 years
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Oxygen administration with Common nasal cannula and Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2015to 28 Feb 2019
- 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 29 days to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- elective flexible bronchoscopy
Who cannot join
- admitted in Neonatal intensive care
- previous respiratory support: oxygen any device, non invasive or invasive ventilation
- patient who may benefit with continuous positive pressure during procedure
About this study
Official title: Oxygen Administration During Bronchoscopy in Children, High Flow and Common Nasal Cannula: a Randomized Controled Trial
Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.
- Conditions
- Respiratory Disease
- Being tested
- Oxygen administration with Common nasal cannula, Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel
- Keywords
- Children, Desaturations, Bronchoscopy, Oxygen, High flow oxygen
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen administration with Common nasal cannulaDevice
Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.
Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and PykelDevice
| Study group | Role | What they receive |
|---|---|---|
| Common nasal cannula | Active comparator | Oxygen administration up to 4 liters according defined protocol Receives: Device: Oxygen administration with Common nasal cannula |
| High flow nasal cannula | Experimental | Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study Receives: Device: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen desaturation
Number of patients with Oxygen saturation under 94% during bronchoscopy
Measured: Trough study completion, an average of 2 years
Secondary outcomes (5)
Moderate oxygen desaturations
Number of patients with Oxygen saturation < 94% and > 90 %
Measured: Trough study completion, an average of 2 years
Severe oxygen desaturations
Number of patients with Oxygen saturation< 90%
Measured: Trough study completion, an average of 2 years
Tachypnea
Number of patients with Breath rate more than p95 fore age for more than 30 seconds
Measured: Trough study completion, an average of 2 years
Apnea
Number of patients with Breath rate 0 for more than 20 seconds or recure intervention
Measured: Trough study completion, an average of 2 years
Bradycardia
Number of patients with Heart rate less than p5 forte age for more than 20 seconds
Measured: Trough study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start10 Nov 2015
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Espases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Artur sharluyan, MD, Principal investigator, Ib-salutSebastian Sailer, MD, Study director, Ib-saludFrancisco de Borja Osona Rodriguez, PhD, Study chair, Ib-salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976167
- Sponsor's protocol ID
- IB 3150/16 PI
- Status last verified
- Jun 2019
- First submitted
- 30 May 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sharluyan A, Osona B, Frontera G, Brandstrup KB, Figuerola J, Sanz-Ruiz I, Salas A, Garrido B, Eva CG, Fernandez A, Pena-Zarza JA, Gil JA, Bover-Bauza C, Sailer S. High flow nasal cannula versus standard low flow nasal oxygen during flexible bronchoscopy in children: A randomized controlled trial. Pediatr Pulmonol. 2021 Dec;56(12):4001-4010. doi: 10.1002/ppul.25655. Epub 2021 Sep 10.
PubMed 34506689
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Administration During Bronchoscopy in Children, High Flow and Common Nasal Cannula: a Randomized Controled Trial
- ClinicalTrials.gov ID
- NCT03976167
- Acronym / sponsor ID
- IB 3150/16 PI
- Conditions
- Respiratory Disease
- Keywords
- Children, Desaturations, Bronchoscopy, Oxygen, High flow oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hospital Son EspasesUniversity, hospital or other
- Study start
- 10 Nov 2015 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 5 Jun 2019 (actual)
- 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.
Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common nasal cannula | Active comparator | Device: Oxygen administration with Common nasal cannulaOxygen administration up to 4 liters according defined protocol |
| High flow nasal cannula | Experimental | Device: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and PykelOxygen administered with high flow nasal cannula according child weight and protocol designed for this study |
Who may qualify
- Ages
- 29 days to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- elective flexible bronchoscopy
Key exclusion criteria (3 listed)
- admitted in Neonatal intensive care
- previous respiratory support: oxygen any device, non invasive or invasive ventilation
- patient who may benefit with continuous positive pressure during procedure
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 |
|---|---|---|
| Oxygen administration with Common nasal cannulaOxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1. | Device | Common nasal cannula |
| Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel | Device | High flow nasal cannula |
Primary outcome
Oxygen desaturation
Time frame: Trough study completion, an average of 2 years
Number of patients with Oxygen saturation under 94% during bronchoscopy
5 secondary outcomes
Moderate oxygen desaturations
Time frame: Trough study completion, an average of 2 years
Severe oxygen desaturations
Time frame: Trough study completion, an average of 2 years
Tachypnea
Time frame: Trough study completion, an average of 2 years
Apnea
Time frame: Trough study completion, an average of 2 years
Bradycardia
Time frame: Trough study completion, an average of 2 years
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 10 Jun 2019.
- Derived from this study: PubMed 34506689Sharluyan A, Osona B, Frontera G, Brandstrup KB, Figuerola J, Sanz-Ruiz I, Salas A, Garrido B, Eva CG, Fernandez A, Pena-Zarza JA, Gil JA, Bover-Bauza C, Sailer S. High flow nasal cannula versus standard low flow nasal oxygen during flexible bronchoscopy in children: A randomized controlled trial. Pediatr Pulmonol. 2021 Dec;56(12):4001-4010. doi: 10.1002/ppul.25655. Epub 2021 Sep 10.
- 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.
Artur sharluyan, MD principal investigator
Ib-salut
Sebastian Sailer, MD study director
Ib-salud
Francisco de Borja Osona Rodriguez, PhD study chair
Ib-salud
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen administration with Common nasal cannula and Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel in people with Respiratory Disease, run by Hospital Son Espases.
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 1 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 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Oxygen desaturation (time frame: Trough study completion, an average of 2 years). 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 NCT03976167, which also lists 1 linked publication.
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 10 Jun 2019.