NCT02253706

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 1, 2014

Status Verified

July 1, 2014

Enrollment Period

1.9 years

First QC Date

September 2, 2014

Last Update Submit

September 28, 2014

Conditions

Hypoxia

Keywords

bronchoscopyhypoxiaoxygen supplementationsafety

Outcome Measures

Primary Outcomes (2)

  • Oxygen desaturation index 4% (ODI4%)

    duration of bronchoscopy with an expected average duration of 30 minutes

  • oxygen cumulative time below 88%(OCT88%)

    beginning to end of bronchoscopy procedure with an expected average duration of 30minutes

Secondary Outcomes (4)

  • number of bradycardic and tachycardic events

    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

    beginning to end of bronchoscopy with an expected average duration of 30 minutes

  • oxygen desaturation index 4%

    preprocedural to 2 hours post procedure with an expected total duration of 3 hours

  • cumulative oxygen time 88%

    pre-procedural to 2 hours post precedure with an expected total duration of 3 hours

Other Outcomes (1)

  • patient comfort during the procedure

    duration of bronchoscopy procedure with an expected average duration of 30 minutes

Study Arms (2)

Low flow nasal oxygen supplementation

ACTIVE COMPARATOR

Low flow nasal oxygen supplementation as per routine standard of care(control arm)

Device: low flow nasal oxygen supplementation

High flow nasal oxygen supplementation

EXPERIMENTAL

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

Interventions

High flow nasal oxygen supplementationDEVICE

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)
High flow nasal oxygen supplementation
low flow nasal oxygen supplementationDEVICE

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.

Low flow nasal oxygen supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled to undergo routine bronchoscopy for diagnostic purposes

You may not qualify if:

  • inability to give an informed consent
  • nasal deformities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 3235, Israel

Location

Related Publications (7)

  • 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.

    PMID: 4809326BACKGROUND

  • 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.

    PMID: 6744959BACKGROUND

  • 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.

    PMID: 23860341BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 22666567BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayal Romem, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayal Romem, MD

CONTACT

97226555676pulmoromem@szmc.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

October 1, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 1, 2014

Record last verified: 2014-07

Locations

IL(1)