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Trial record 65 of 424 for:    shaare zedek

Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen

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ClinicalTrials.gov Identifier: NCT02253706
Recruitment Status : Unknown
Verified July 2014 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

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.


Condition or disease Intervention/treatment Phase
Hypoxia Device: High flow nasal oxygen supplementation Device: low flow nasal oxygen supplementation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula
Study Start Date : October 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Low flow nasal oxygen supplementation
Low flow nasal oxygen supplementation as per routine standard of care(control arm)
Device: low 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.

Experimental: 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
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.
Other Name: Precision Flow device (Opti-Flow, Auckland, New Zealand)




Primary Outcome Measures :
  1. Oxygen desaturation index 4% (ODI4%) [ Time Frame: duration of bronchoscopy with an expected average duration of 30 minutes ]
  2. oxygen cumulative time below 88%(OCT88%) [ Time Frame: beginning to end of bronchoscopy procedure with an expected average duration of 30minutes ]

Secondary Outcome Measures :
  1. number of bradycardic and tachycardic events [ Time Frame: beginning to end of bronchoscopy with an expected averag duration of 30 minutes ]
  2. 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 ]
  3. oxygen desaturation index 4% [ Time Frame: preprocedural to 2 hours post procedure with an expected total duration of 3 hours ]
  4. cumulative oxygen time 88% [ Time Frame: pre-procedural to 2 hours post precedure with an expected total duration of 3 hours ]

Other Outcome Measures:
  1. patient comfort during the procedure [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled to undergo routine bronchoscopy for diagnostic purposes

Exclusion Criteria:

  • inability to give an informed consent
  • nasal deformities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253706


Contacts
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Contact: Ayal Romem, MD 97226555676 pulmoromem@szmc.org.il

Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 3235
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Ayal Romem, MD Shaare Zedek Medical Center

Publications:
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Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02253706     History of Changes
Other Study ID Numbers: HFO-Rx1
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: July 2014
Keywords provided by Shaare Zedek Medical Center:
bronchoscopy
hypoxia
oxygen supplementation
safety
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms