High Flow Nasal Cannula With Noninvasive Ventilation

NCT04507425 | Completed

• 1 other identifier: 12248
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, unblinded trial of trauma patients in the ICU who are identified as being at a high risk to develop acute respiratory failure. We hope that this study will help the study team to identify how best to use a more aggressive respiratory treatment strategy in a high risk trauma population (thoracic trauma or trauma patients requiring thoracic surgery, spine surgery, or open abdominal procedures) to try and decrease the need for intubation with mechanical ventilation.

Conditions

Acute Respiratory Failure

Keywords

acute respiratory failure; mechanical ventilation

Outcome Measures

Primary Outcomes (2)

• failure rates-nonintubated patients

  Among injured patients admitted to the intensive care unit (ICU) without being intubated, do failure rates within the first 48 hours of ICU admission differ with respect to type of initial respiratory intervention: nasal cannula, high-flow nasal cannula (HFNC), or HFNC plus non-invasive ventilation (BiPAP). Failure is defined as escalation to intubation.

  first 48 hours

• failure rates-intubated patients

  Among injured patients arriving intubated or who undergo intervention after hospital arrival, do failure rates within the first 48 hours after extubation differ with respect to type of initial respiratory intervention: nasal cannula, high-flow nasal cannula (HFNC), or HFNC plus non-invasive ventilation (BiPAP). Failure is defined as requiring reintubation.

  first 48 hours

Secondary Outcomes (5)

• Mortality

  Up to 2 years

• Length of hospital stay

  up to 60 days

• Length of ICU stay

  up to 30 days

• Discharge location

  up to 60 days

• Complications

  up to 2 years

Study Arms (2)

Not Intubated

ACTIVE COMPARATOR

Patients admitted with a trauma injury who do not need to be intubated to receive treatment. Intubated means putting a tube down your throat to keep your airway from collapsing. Participants will be randomized to receive one of the three interventions in this arm.

Other: Standard of Care - Nasal Cannula; Other: High-flow nasal cannula; Other: HFNC plus non-invasive ventilation

Intubated Patients Undergoing Extubation

ACTIVE COMPARATOR

Patients admitted with a trauma injury who had to be intubated for treatment of their injury. Interventions administered after the tube is extubated (removed from throat). Participants will be randomized to receive one of the three interventions in this arm.

Other: Standard of Care - Nasal Cannula; Other: High-flow nasal cannula; Other: HFNC plus non-invasive ventilation

Interventions

Standard of Care - Nasal Cannula OTHER

Standard of care. Flexible tube to provide extra oxygen when patients need a little help, but are not in respiratory distress.

Intubated Patients Undergoing Extubation; Not Intubated

High-flow nasal cannula OTHER

Same as nasal cannula, except the oxygen is heated or humidified and the flow is stronger, pushing air into the lungs to help keep the airway open.

Also known as: HFNC

Intubated Patients Undergoing Extubation; Not Intubated

HFNC plus non-invasive ventilation OTHER

This method uses HFNC as described above and adds noninvasive ventilation which is similar to CPAP machine and uses a mask rather than having to intubate (putting a tube down your throat to keep your airway from collapsing).

Intubated Patients Undergoing Extubation; Not Intubated

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 18 years of age
• Admission to an intensive care unit by the trauma surgery service
• Trauma patients receiving any respiratory therapies
• High risk patients, including intubation, post-operative, chronic cardiac or pulmonary comorbidities
• Thoracic injuries, including rib fractures, sternal fractures, spinal fractures, pulmonary contusions, pneumothorax, hemothorax, diaphragm injury
• Postoperative from thoracic surgery
• Postoperative from spine surgery in patients without spinal cord injury
• Abdominal injuries requiring open abdominal surgery
• No contraindications to using high flow nasal cannula or noninvasive ventilation

You may not qualify if:

• Contraindication to using high flow nasal cannula or noninvasive ventilation
• Intolerance of pulmonary therapies
• No one able to give informed consent
• Long-term treatment with noninvasive ventilation prior to hospital admission
• "Do not intubate" order at time of extubation
• Unplanned extubation (accidental or self-extubation)
• Age \< 18 years of age
• Traumatic brain injury with GCS \< 8
• Spinal cord injury
• Chronic neuromuscular disease
• Sinus precautions due to facial/sinus fractures

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (7)

• Thille AW, Boissier F, Ben-Ghezala H, Razazi K, Mekontso-Dessap A, Brun-Buisson C, Brochard L. Easily identified at-risk patients for extubation failure may benefit from noninvasive ventilation: a prospective before-after study. Crit Care. 2016 Feb 26;20:48. doi: 10.1186/s13054-016-1228-2.

  PMID: 26926168 RESULT

• Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901.

  PMID: 31577036 RESULT

• Xu Z, Li Y, Zhou J, Li X, Huang Y, Liu X, Burns KEA, Zhong N, Zhang H. High-flow nasal cannula in adults with acute respiratory failure and after extubation: a systematic review and meta-analysis. Respir Res. 2018 Oct 16;19(1):202. doi: 10.1186/s12931-018-0908-7.

  PMID: 30326893 RESULT

• Honrubia T, Garcia Lopez FJ, Franco N, Mas M, Guevara M, Daguerre M, Alia I, Algora A, Galdos P. Noninvasive vs conventional mechanical ventilation in acute respiratory failure: a multicenter, randomized controlled trial. Chest. 2005 Dec;128(6):3916-24. doi: 10.1378/chest.128.6.3916.

  PMID: 16354864 RESULT

• Halub ME, Spilman SK, Gaunt KA, Lamb KD, Jackson JA, Oetting TW, Sahr SM. High-flow nasal cannula therapy for patients with blunt thoracic injury: A retrospective study. Can J Respir Ther. 2016 Fall;52(4):110-113. Epub 2016 Nov 1.

  PMID: 30996619 RESULT

• Gaunt KA, Spilman SK, Halub ME, Jackson JA, Lamb KD, Sahr SM. High-Flow Nasal Cannula in a Mixed Adult ICU. Respir Care. 2015 Oct;60(10):1383-9. doi: 10.4187/respcare.04016. Epub 2015 Jun 9.

  PMID: 26060320 RESULT

• Lamb KD, Spilman SK, Oetting TW, Jackson JA, Trump MW, Sahr SM. Proactive Use of High-Flow Nasal Cannula With Critically Ill Subjects. Respir Care. 2018 Mar;63(3):259-266. doi: 10.4187/respcare.05793. Epub 2017 Dec 5.

  PMID: 29208754 RESULT

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Celia Y Quang, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants will be randomized into 1 of 3 interventions: nasal cannula, high flow nasal cannula, and high flow nasal cannula plus noninvasive ventilation within each of two groups: patients admitted to ICU without being intubated OR intubated patients undergoing an extubation.

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: August 11, 2020
• Study Start: September 1, 2020
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)