Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen

Hypoxia Clinical Trial

Official title:

Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02253706
• Other study ID #: HFO-Rx1
• Status: Not yet recruiting
• Phase: N/A
• First received: September 2, 2014
• Last updated: September 28, 2014
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: July 2014
• Source: Shaare Zedek Medical Center
• Contact: Ayal Romem, MD
• Phone: 97226555676
• Email: pulmoromem[@]szmc.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled to undergo routine bronchoscopy for diagnostic purposes

Exclusion Criteria:

• inability to give an informed consent

• nasal deformities

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypoxia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (7)

Albertini R, Harrel JH, Moser KM. Letter: Hypoxemia during fiberoptic bronchoscopy. Chest. 1974 Jan;65(1):117-8. — View 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. — View 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

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. — View 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. — View 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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	duration of bronchoscopy procedure with an expected average duration of 30 minutes	No
Primary	Oxygen desaturation index 4% (ODI4%)		duration of bronchoscopy with an expected average duration of 30 minutes	Yes
Primary	oxygen cumulative time below 88%(OCT88%)		beginning to end of bronchoscopy procedure with an expected average duration of 30minutes	Yes
Secondary	number of bradycardic and tachycardic events		beginning to end of bronchoscopy with an expected averag duration of 30 minutes	Yes
Secondary	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	Yes
Secondary	oxygen desaturation index 4%		preprocedural to 2 hours post procedure with an expected total duration of 3 hours	Yes
Secondary	cumulative oxygen time 88%		pre-procedural to 2 hours post precedure with an expected total duration of 3 hours	Yes