Clinical trial NCT02253706: Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen
Official title: Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
Keywords: bronchoscopy
hypoxia
oxygen supplementation
safety
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* patients scheduled to undergo routine bronchoscopy for diagnostic purposes

Exclusion Criteria:

* inability to give an informed consent
* nasal deformities

Primary outcomes:
measure: Oxygen desaturation index 4% (ODI4%)
timeFrame: duration of bronchoscopy with an expected average duration of 30 minutes
measure: oxygen cumulative time below 88%(OCT88%)
timeFrame: beginning to end of bronchoscopy procedure with an expected average duration of 30minutes
Secondary outcomes:
measure: number of bradycardic and tachycardic events
timeFrame: beginning to end of bronchoscopy with an expected averag duration of 30 minutes
measure: change in expired end tidal carbon dioxide before and after completion of bronchoscopy
timeFrame: beginning to end of bronchoscopy with an expected average duration of 30 minutes
measure: oxygen desaturation index 4%
timeFrame: preprocedural to 2 hours post procedure with an expected total duration of 3 hours
measure: cumulative oxygen time 88%
timeFrame: pre-procedural to 2 hours post precedure with an expected total duration of 3 hours
Other outcomes:
measure: patient comfort during the procedure
timeFrame: duration of bronchoscopy procedure with an expected average duration of 30 minutes
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Ayal Romem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albertini R, Harrel JH, Moser KM. Letter: Hypoxemia during fiberoptic bronchoscopy. Chest. 1974 Jan;65(1):117-8. doi: 10.1378/chest.65.1.117. No abstract available.
citation: Matsushima Y, Jones RL, King EG, Moysa G, Alton JD. Alterations in pulmonary mechanics and gas exchange during routine fiberoptic bronchoscopy. Chest. 1984 Aug;86(2):184-8. doi: 10.1378/chest.86.2.184.
citation: Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.
citation: Roca O, Masclans JR, Laborda C, Sacanell J, Serra J. High-flow nasal cannula improves oxygenation in hypoxemic respiratory failure. Intensive Care Med 2007; 33:S86
citation: Williams AB, Ritchie JE, Gerard C. Evaluation of a high-flow nasal oxygen delivery system: gas analysis and pharyngeal pressures. Intensive Care Med 2006; 32: S219
citation: Lomas C, Roca O, Alvarez A, Masclans JR. Fibroscopy in patients with hypoxemic respiratory insufficiency: Utility of the high-flow nasal cannula. Respr Med (CME) 2009; 2: 121-124
citation: Lucangelo U, Vassallo FG, Marras E, Ferluga M, Beziza E, Comuzzi L, Berlot G, Zin WA. High-flow nasal interface improves oxygenation in patients undergoing bronchoscopy. Crit Care Res Pract. 2012;2012:506382. doi: 10.1155/2012/506382. Epub 2012 May 20.