Humidity Therapy for Spontaneously Breathing Tracheostomy Patients

NCT02686489 | Terminated

• 1 other identifier: 16010603
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to compare the safety and efficacy of molecular water and bland aerosol therapy (particulate water) in providing adequate humidity to the inspired gas of spontaneously breathing tracheostomy patients.

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Clinical pulmonary infection score (CPIS)

  Pulmonary infection rate as determined by CPIS score

  Within the first 7 days of initiation of the intervention

Secondary Outcomes (4)

• Incidences of tracheostomy tube occlusion with respiratory secretions (mucus plugging of tracheostomy tube)

  Within the first 7 days of initiation of the intervention

• Pulmonary complications

  Within the first 7 days of initiation of the intervention

• Cost of care

  Within 3 months of the study's completion date

• Length of hospital stay

  Within 3 months of the study's completion date

Study Arms (2)

Heated humidification (HH)

EXPERIMENTAL

Addition of water vapor (molecular water) to the inspired gas of spontaneously breathing tracheostomy patients.

Other: Heated humidification

Cool bland aerosol (LVN)

ACTIVE COMPARATOR

Addition of particulate water to the inspired gas of spontaneously breathing tracheostomy patients.

Other: Cool bland aerosol

Interventions

Heated humidification OTHER

Water vapor (molecular water) will be added to the inspired gas of the spontaneously breathing tracheostomy patient by using the Fisher \& Paykel Healthcare, (Auckland, New Zealand) AIRVO 2 Humidification System. The AIRVO 2 will provide respiratory gas flow at 2-60 L/min) that is conditioned to 37° C, 34° C, or 31° C (based on patient comfort) and 100% relative humidity via a heated breathing circuit.

Heated humidification (HH)

Cool bland aerosol OTHER

Aerosol (particles of water suspended in gas) generated by a flow of gas through a pneumatically powered large volume jet nebulizer filled with sterile water (for inhalation) attached to a gas source via a flowmeter set between 10-15 L/min will add moisture to the inspired gas of the spontaneously breathing tracheostomy patient. The cold bland aerosol set-up will consist of corrugated aerosol tubing with one end connected to the nebulizer output port and the other end connected to a tracheostomy mask.

Cool bland aerosol (LVN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than eighteen years old
• Tracheotomized less than or equal to two weeks before entry into the study
• Spontaneously breathing

You may not qualify if:

• Less than eighteen years old
• Tracheotomy performed more than two weeks prior to enrolment in the study
• Mechanically ventilated

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University

Chicago, Illinois, 60612, United States

Location

Related Publications (17)

• Edwards EA, Byrnes CA. Humidification difficulties in two tracheostomized children. Anaesth Intensive Care. 1999 Dec;27(6):656-8. doi: 10.1177/0310057X9902700618.

  PMID: 10631425 BACKGROUND

• McNamara DG, Asher MI, Rubin BK, Stewart A, Byrnes CA. Heated humidification improves clinical outcomes, compared to a heat and moisture exchanger in children with tracheostomies. Respir Care. 2014 Jan;59(1):46-53. doi: 10.4187/respcare.02214. Epub 2013 Jun 13.

  PMID: 23764867 BACKGROUND

• Kuo CD, Lin SE, Wang JH. Aerosol, humidity and oxygenation. Chest. 1991 Jun;99(6):1352-6. doi: 10.1378/chest.99.6.1352.

  PMID: 2036815 BACKGROUND

• Rozsasi A, Durr J, Leiacker R, Keck T. Delivery of molecular versus particulate water in spontaneously breathing tracheotomized patients. Head Neck. 2007 Jan;29(1):52-7. doi: 10.1002/hed.20473.

  PMID: 16983692 BACKGROUND

• Kacmarek, Robert, James Stoller, Albert Heuer. Egan's Fundamentals of Respiratory Care, 10th Edition. Mosby, 2013. VitalBook file.

  BACKGROUND

• Williams R, Rankin N, Smith T, Galler D, Seakins P. Relationship between the humidity and temperature of inspired gas and the function of the airway mucosa. Crit Care Med. 1996 Nov;24(11):1920-9. doi: 10.1097/00003246-199611000-00025.

  PMID: 8917046 BACKGROUND

• The Global Tracheostomy Collaborative. Tracheostomy 101. Retrieved 12/15/2015 at http://globaltrach.org/tracheostomy.

  BACKGROUND

• Yu M. Tracheostomy patients on the ward: multiple benefits from a multidisciplinary team? Crit Care. 2010;14(1):109. doi: 10.1186/cc8218. Epub 2010 Jan 29.

  PMID: 20156313 BACKGROUND

• Agency for Healthcare Research and Quality (AHRQ), HCUP-net National and regional estimates on hospital use for all patients from the HCUP Nationwide Inpatient Sample (NIS), 2009.

  BACKGROUND

• Freeman BD, Stwalley D, Lambert D, Edler J, Morris PE, Medvedev S, Hohmann SF, Kymes SM. High resource utilization does not affect mortality in acute respiratory failure patients managed with tracheostomy. Respir Care. 2013 Nov;58(11):1863-72. doi: 10.4187/respcare.02359. Epub 2013 Apr 30.

  PMID: 23650434 BACKGROUND

• Wilkinson KA, Freeth H, Martin IC. Are we 'on the right trach?' The National Confidential Enquiry into Patient Outcome and Death examines tracheostomy care. J Laryngol Otol. 2015 Mar;129(3):212-6. doi: 10.1017/S0022215115000158. Epub 2015 Feb 3.

  PMID: 25645673 BACKGROUND

• Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18.

  PMID: 22990518 BACKGROUND

• Cetto R, Arora A, Hettige R, Nel M, Benjamin L, Gomez CM, Oldfield WL, Narula AA. Improving tracheostomy care: a prospective study of the multidisciplinary approach. Clin Otolaryngol. 2011 Oct;36(5):482-8. doi: 10.1111/j.1749-4486.2011.02379.x.

  PMID: 21838807 BACKGROUND

• Volsko, Teresa A., Robert L. Chatburn, and Mohamad F. El-Khatib.

  BACKGROUND

• American Association for Respiratory Care; Restrepo RD, Walsh BK. Humidification during invasive and noninvasive mechanical ventilation: 2012. Respir Care. 2012 May;57(5):782-8. doi: 10.4187/respcare.01766.

  PMID: 22546299 BACKGROUND

• Branson RD, Davis K Jr, Campbell RS, Johnson DJ, Porembka DT. Humidification in the intensive care unit. Prospective study of a new protocol utilizing heated humidification and a hygroscopic condenser humidifier. Chest. 1993 Dec;104(6):1800-5. doi: 10.1378/chest.104.6.1800.

  PMID: 8252968 BACKGROUND

• Kelly M, Gillies D, Todd DA, Lockwood C. Heated humidification versus heat and moisture exchangers for ventilated adults and children. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD004711. doi: 10.1002/14651858.CD004711.pub2.

  PMID: 20393939 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 19, 2016
• Study Start: March 24, 2017
• Primary Completion: August 11, 2018
• Study Completion: August 11, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)