High-Flow Oxygen Therapy Following Tracheostomy

NCT03721419 | Completed DMC FDA Device

• 1 other identifier: 201707165
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Days of Mechanical Ventilation (MV)

  Time in days from initiation of MV until discontinuance of MV

  an average of 1 year

Secondary Outcomes (2)

• Days of ICU Stay

  an average of 1 year

• Days of hospital stay

  an average of 1 year

Study Arms (2)

High Flow High Humidity device

EXPERIMENTAL

High Flow High Humidity device arm subjects will be placed on a High Flow Airvo device post tracheostomy with oxygen bled into system which maintains a safe level of patient blood oxygen. This device has its own flow generator built in.

Device: High Flow High Humidity device

Low Flow High Humidity Device

ACTIVE COMPARATOR

Low Flow High Humidity device arm patients will be placed on a Low Flow device post tracheostomy with oxygen bled into system which maintains a safe level of patient blood oxygen.

Device: Low Flow High Humidity device

Interventions

High Flow High Humidity device 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)

Also known as: Airvo high flow device

High Flow High Humidity device

Low Flow High Humidity device DEVICE

Standard high humidity trach collar utilizing venturi device bleed in

Also known as: High Humidity Trach Collar

Low Flow High Humidity Device

Eligibility Criteria

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

You may qualify if:

• Mechanically ventilated patients who receive tracheostomy

You may not qualify if:

• Non-English speaking and pregnancy

Sponsors & Collaborators

• Barnes-Jewish Hospital: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• Ferrer M, Sellares 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.

  PMID: 19682735 BACKGROUND

• 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.

  PMID: 19344515 BACKGROUND

• 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.

  PMID: 22879654 BACKGROUND

• 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. doi: 10.1164/rccm.200505-718OC. Epub 2005 Oct 13.

  PMID: 16224108 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000186416.44752.72.

  PMID: 16276167 BACKGROUND

Study Officials

• Marin Kollef, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager, Respiratory Therapy

Model Details: Crossover study between 2 medical ICUs and 1 Surgical ICU. Patients in one unit will start off with Low Flow (LF) while the other unit will start off with High Flow (HF). After one half of the required sample size is accrued we will crossover the Medicine ICUs with the Surgical ICU.

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: October 26, 2018
• Study Start: May 17, 2018
• Primary Completion: March 30, 2020
• Study Completion: April 7, 2020
• Last Updated: July 20, 2021

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)