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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03721419
Other study ID # 201707165
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 17, 2018
Est. completion date April 7, 2020

Study information

Verified date July 2019
Source Barnes-Jewish Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Respiratory failure patients sometimes receive tracheostomy due to difficulty weaning from mechanical ventilation. Efforts to wean patients with a tracheostomy usually involve the administration of oxygen via High Humidity device. There are two major ways of administering oxygen to patients which include low flow delivered at less than 10Liters per minute (LPM) and high-flow delivered at greater than 10LPM. There is not a currently accepted standard of care practice for how to administer oxygen therapy to these patients. Both Low and High Flow are accepted practices in the US.


Description:

Many patients with Respiratory Failure undergo tracheostomy due to difficulty weaning from mechanical ventilation. A component of weaning a patient with tracheostomy usually involves the administration of oxygen via High Humidity device. There are two major ways of administering oxygen via High Humidity to patients. They include low flow high humidity; delivered at less than or equal to 10LPM or high-flow humidity, delivered at greater than 10LPM. There is not a currently accepted standard of practice for how to administer oxygen high humidity to patients who receive a tracheostomy due to respiratory failure. Both Low and High Flow high humidity devices are used routinely by health care facilities nationwide. Therefore, the investigators plan to perform a crossover study in both a medicine and surgical Intensive Care Unit to determine which type of oxygen High Humidity therapy should be preferentially utilized. Patients in one Intensive Care Unit will start off with Low Flow high humidity while the alternate unit will start with Hi Flow high humidity. After one half of the required sample size is accrued the investigators will cross over the two ICUs to the alternate type of oxygen High Humidity device. No other respiratory practices will change during the conduct of this trial.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date April 7, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Mechanically ventilated patients who receive tracheostomy Exclusion Criteria: - Non-English speaking and pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
High Flow High Humidity device
High Flow High Humidity device has a flow generator built into the body of unit and can deliver flows between 10 to 60 Liters per minute (LPM) with oxygen bled in as needed in order to deliver specified Fraction of inspired Oxygen (FiO2)
Low Flow High Humidity device
Standard high humidity trach collar utilizing venturi device bleed in

Locations

Country Name City State
United States Barnes-Jewish Hospital Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Ferrer M, Sellarés J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12. — View Citation

Ferrer M, Valencia M, Nicolas JM, Bernadich O, Badia JR, Torres A. Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial. Am J Respir Crit Care Med. 2006 Jan 15;173(2):164-70. Epub 2005 Oct 13. — View Citation

Glossop AJ, Shephard N, Bryden DC, Mills GH. Non-invasive ventilation for weaning, avoiding reintubation after extubation and in the postoperative period: a meta-analysis. Br J Anaesth. 2012 Sep;109(3):305-14. doi: 10.1093/bja/aes270. Review. Erratum in: Br J Anaesth. 2013 Jan;110(1):164. Shepherd, N [corrected to Shephard, N]. — View Citation

Jaber S, Jung B, Chanques G, Bonnet F, Marret E. Effects of steroids on reintubation and post-extubation stridor in adults: meta-analysis of randomised controlled trials. Crit Care. 2009;13(2):R49. doi: 10.1186/cc7772. Epub 2009 Apr 3. — View Citation

Nava S, Gregoretti C, Fanfulla F, Squadrone E, Grassi M, Carlucci A, Beltrame F, Navalesi P. Noninvasive ventilation to prevent respiratory failure after extubation in high-risk patients. Crit Care Med. 2005 Nov;33(11):2465-70. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Days of Mechanical Ventilation (MV) Time in days from initiation of MV until discontinuance of MV an average of 1 year
Secondary Days of ICU Stay The number of days the subject is in the ICU an average of 1 year
Secondary Days of hospital stay Time in days from admission to hospital until discharge from hospital an average of 1 year
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