High Flow Nasal Cannula With Noninvasive Ventilation

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    1770
  • sponsor
    University of Oklahoma
Updated on 27 January 2021

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.

Description

All patients consented will be randomly assigned into one of three groups: nasal cannula (control group, our current standard of care), high-flow nasal cannula, high-flow nasal cannula plus noninvasive ventilation.

After obtaining consent, patient will be randomized to interventions 1:1:1 within each of two groups: patients admitted to the ICU without being intubated OR intubated patients undergoing an extubation.

Randomization will be managed through RedCap. After consent, the treating clinician will log into RedCap to obtain the patient's treating assignment.

The primary outcome of interest is failure of conservative ventilation intervention in prevention of initial intubation or prevention of reintubation.

A chart review of all enrolled patients will be done quarterly to assess morbidity, mortality, and outcomes.

No placebo will be used as all qualifying patients will be placed on nasal cannula, high-flow nasal cannula, or high-flow nasal cannula plus noninvasive ventilation. All other treatments will be standard of care.

Participants in the study will continue until the patient is discharged from the trauma ICU.

The study will end when the last person enrolled has been discharged from the trauma ICU. If patient's participation ends prematurely, available data will be entered into the database and evaluated appropriately.

This study will take place at the OU Medical Center (OUMC) among patients admitted to the Trauma Intensive Care Unit.

Consent for study enrollment will take place at OUMC during discussion with physician providing trauma care and the patient, family member, or next of kin consenting for the study.

The following data will be collected and recorded: Supplemental oxygen requirements, Date/Time of arrival, Date/Time of Admission to ICU, Date/Time of intubation procedure, Date/Time of extubation, Ventilator settings, Duration of intubation, Comorbidities, PaCO2 values, PaO2 values, Vital signs at arrival and at admission to ICU, Age,Gender, Weight, Height, BMI, Traumatic injuries, Diagnosis, Past medical history/medical co-morbidities, Glasgow coma scale, Oxygen saturation, Negative inspiratory force score, Rapid shallow breathing index score, Pulmonary treatments, including an intolerance to therapy, Injury Severity Score (ISS) and/or Abbreviated Injury Scale (AIS).

Details
Condition Acute Respiratory Failure
Treatment High-Flow Nasal Cannula, Standard of Care - Nasal Cannula, HFNC plus non-invasive ventilation
Clinical Study IdentifierNCT04507425
SponsorUniversity of Oklahoma
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Acute Respiratory Failure??
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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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