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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Common nasal cannula | Active Comparator | Oxygen administration up to 4 liters according defined protocol |
|
| High flow nasal cannula | Experimental | Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen administration with Common nasal cannula | Device | Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen desaturation | Number of patients with Oxygen saturation under 94% during bronchoscopy | Trough study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate oxygen desaturations | Number of patients with Oxygen saturation < 94% and > 90 % | Trough study completion, an average of 2 years |
| Severe oxygen desaturations | Number of patients with Oxygen saturation< 90% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Artur sharluyan, MD | Ib-salut | Principal Investigator |
| Sebastian Sailer, MD | Ib-salud | Study Director |
| Francisco de Borja Osona Rodriguez, PhD | Ib-salud | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34506689 | Derived | 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. |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel | Device |
|
| 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 | Trough study completion, an average of 2 years |
| Apnea | Number of patients with Breath rate 0 for more than 20 seconds or recure intervention | 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 | Trough study completion, an average of 2 years |