Hypoxia
Conditions
Keywords
bronchoscopy, hypoxia, oxygen supplementation, safety
Brief summary
In general bronchoscopy is a safe procedure with low rate of complications. Indeed, contraindications to flexible bronchoscopy are mostly relative rather than absolute. This is the case of preexisting decreased blood oxygen levels which may be present in patients requiring further bronchopulmonary investigation. To avoid the deleterious effects of oxygen drops oxygen supplementation is recommended. The purpose of this study is to evaluate the efficiency and safety of oxygen supplementation obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula during flexible bronchoscopy. Consecutive patients referred by their treating physician for bronchoscopy will be offered to take part in the study. Those who wish to participate and give their consent will be randomly assigned into one of two treatment groups (supplemental oxygen given via low flow nasal cannula or via high flow nasal cannula). Assignment to either treatment arm will not affect in any way the intended purpose of the bronchoscopy. All patients will be closely monitored during the procedure and 2 hours following its completion. Monitoring will be conducted, using strictly non-invasive measures.
Interventions
DEVICEHigh flow nasal oxygen supplementation
High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35.
DEVICElow flow nasal oxygen supplementation
Low-flow nasal ventilation: This will be carried out using a regular nasal cannula fed with oxygen at flow rates from 2 to 6 liters/minute.
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients scheduled to undergo routine bronchoscopy for diagnostic purposes
Exclusion criteria
* inability to give an informed consent * nasal deformities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oxygen cumulative time below 88%(OCT88%) | beginning to end of bronchoscopy procedure with an expected average duration of 30minutes |
| Oxygen desaturation index 4% (ODI4%) | duration of bronchoscopy with an expected average duration of 30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| change in expired end tidal carbon dioxide before and after completion of bronchoscopy | beginning to end of bronchoscopy with an expected average duration of 30 minutes |
| cumulative oxygen time 88% | pre-procedural to 2 hours post precedure with an expected total duration of 3 hours |
| oxygen desaturation index 4% | preprocedural to 2 hours post procedure with an expected total duration of 3 hours |
| number of bradycardic and tachycardic events | beginning to end of bronchoscopy with an expected averag duration of 30 minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| patient comfort during the procedure | duration of bronchoscopy procedure with an expected average duration of 30 minutes | a numeric rating scale ranging from 1(excellent to 4(poor ) will be filled out by the patient after completion of the bronchoscopy |
Countries
Israel
Contacts
Primary ContactAyal Romem, MD
Outcome results
None listed