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Completed

NCT Number: NCT04507425

High Flow Nasal Cannula With Noninvasive Ventilation

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

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.

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.

Other names: HFNC

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).

Primary outcomes

  1. failure rates-nonintubated patients

    Time frame: first 48 hours

    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.

  2. failure rates-intubated patients

    Time frame: first 48 hours

    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.

Secondary outcomes

  1. Mortality

    Time frame: Up to 2 years

    Assess mortality of enrolled patients by quarterly retrospective chart reviews.

  2. Length of hospital stay

    Time frame: up to 60 days

    Compare length of hospitalization between groups

  3. Length of ICU stay

    Time frame: up to 30 days

    Compare length of ICU stay between groups

  4. Discharge location

    Time frame: up to 60 days

    was patient discharged to home, rehabilitation facility, skilled nursing, death; compare between groups

  5. Complications

    Time frame: up to 2 years

    Compare complications (such as need to be mechanically ventilated, infections, etc.) between groups

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

High Flow Nasal Cannula With Noninvasive Ventilation and Its Effect on High Risk Trauma Patients

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2020
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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