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出境医 / 临床实验 / Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy
Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy
Study Description
Brief 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. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Respiratory Disease | Device: Oxygen administration with Common nasal cannula Device: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 108 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Oxygen Administration During Bronchoscopy in Children, High Flow and Common Nasal Cannula: a Randomized Controled Trial |
| Actual Study Start Date : | November 10, 2015 |
| Actual Primary Completion Date : | February 28, 2019 |
| Actual Study Completion Date : | February 28, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Common nasal cannula
Oxygen administration up to 4 liters according defined protocol
|
Device: Oxygen administration with Common nasal cannula
Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.
|
|
Experimental: High flow nasal cannula
Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study
|
Device: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel |
Outcome Measures
Primary Outcome Measures :
- Oxygen desaturation [ Time Frame: Trough study completion, an average of 2 years ]Number of patients with Oxygen saturation under 94% during bronchoscopy
Secondary Outcome Measures :
- Moderate oxygen desaturations [ Time Frame: Trough study completion, an average of 2 years ]Number of patients with Oxygen saturation < 94% and > 90 %
- Severe oxygen desaturations [ Time Frame: Trough study completion, an average of 2 years ]Number of patients with Oxygen saturation< 90%
- Tachypnea [ Time Frame: Trough study completion, an average of 2 years ]Number of patients with Breath rate more than p95 fore age for more than 30 seconds
- Apnea [ Time Frame: Trough study completion, an average of 2 years ]Number of patients with Breath rate 0 for more than 20 seconds or recure intervention
- Bradycardia [ Time Frame: Trough study completion, an average of 2 years ]Number of patients with Heart rate less than p5 forte age for more than 20 seconds
Eligibility Criteria
| Ages Eligible for Study: | up to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- elective flexible bronchoscopy
Exclusion Criteria:
- 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
Contacts and Locations
Sponsors and Collaborators
Hospital Son Espases
Investigators
| Principal Investigator: | Artur sharluyan, MD | Ib-salut | |
| Study Director: | Sebastian Sailer, MD | Ib-salud | |
| Study Chair: | Francisco de Borja Osona Rodriguez, PhD | Ib-salud |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 30, 2019 | |||||||||
| First Posted Date ICMJE | June 5, 2019 | |||||||||
| Last Update Posted Date | June 10, 2019 | |||||||||
| Actual Study Start Date ICMJE | November 10, 2015 | |||||||||
| Actual Primary Completion Date | February 28, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Oxygen desaturation [ Time Frame: Trough study completion, an average of 2 years ] Number of patients with Oxygen saturation under 94% during bronchoscopy
|
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy | |||||||||
| Official Title ICMJE | Oxygen Administration During Bronchoscopy in Children, High Flow and Common Nasal Cannula: a Randomized Controled Trial | |||||||||
| Brief 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. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE | Respiratory Disease | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
108 | |||||||||
| Original Actual Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date ICMJE | February 28, 2019 | |||||||||
| Actual Primary Completion Date | February 28, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 16 Years (Child) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Not Provided | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03976167 | |||||||||
| Other Study ID Numbers ICMJE | IB 3150/16 PI | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE |
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| Responsible Party | Hospital Son Espases | |||||||||
| Study Sponsor ICMJE | Hospital Son Espases | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Hospital Son Espases | |||||||||
| Verification Date | June 2019 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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