An interventional study of High flow nasal oxygen supplementation and low flow nasal oxygen supplementation in Hypoxia, sponsored by Shaare Zedek Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-01.
Sponsored by Shaare Zedek Medical Center · Not applicable, Interventional, and Supportive care
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.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Shaare Zedek Medical Center is the lead sponsor of 191 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low flow nasal oxygen supplementation as per routine standard of care(control arm)
Device: low 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
Device: High 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.
Also known as: Precision Flow device (Opti-Flow, Auckland, New Zealand)
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.
Oxygen desaturation index 4% (ODI4%)
Time frame: duration of bronchoscopy with an expected average duration of 30 minutes
oxygen cumulative time below 88%(OCT88%)
Time frame: beginning to end of bronchoscopy procedure with an expected average duration of 30minutes
number of bradycardic and tachycardic events
Time frame: beginning to end of bronchoscopy with an expected averag duration of 30 minutes
change in expired end tidal carbon dioxide before and after completion of bronchoscopy
Time frame: beginning to end of bronchoscopy with an expected average duration of 30 minutes
oxygen desaturation index 4%
Time frame: preprocedural to 2 hours post procedure with an expected total duration of 3 hours
cumulative oxygen time 88%
Time frame: pre-procedural to 2 hours post precedure with an expected total duration of 3 hours
patient comfort during the procedure
a numeric rating scale ranging from 1(excellent to 4(poor ) will be filled out by the patient after completion of the bronchoscopy
Time frame: duration of bronchoscopy procedure with an expected average duration of 30 minutes
This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shaare Zedek Medical Center