Clinical trial NCT05675345: Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
Official title: Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure: A Pilot Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Hypoxemic Respiratory Failure
Keywords: acute respiratory distress syndrome
noninvasive ventilation
mechanical ventilation
oxygen inhalation therapy
atelectasis
high-flow nasal cannula
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate if wearing a non-invasive breathing support device over the chest/abdomen improves markers of breathing in patients with lung injury requiring high-flow oxygen. The breathing support device consists of a plastic shell that sits over the chest and abdomen and connects to a vacuum that helps the chest expand with breathing. This breathing support is known as continuous negative external pressure (CNEP). Study findings will help determine if this breathing support device might be useful for patients with acute hypoxemic respiratory failure (AHRF).

Detailed description: This study is a prospective randomized cross-over trial. Eligible, consenting participants will undergo 4 strategies of respiratory support: high-flow nasal cannula (HFNC) only, HFNC + continuous negative external pressure (CNEP) of 10 cmH2O, HFNC + CNEP of 20 cmH2O, HFNC + CNEP of 30 cmH2O. Throughout the study period, HFNC will be managed at a constant flow rate with fraction of inspired oxygen (FiO2) titrated to achieve goal oxygen saturation (SpO2) of 90-97%, measured via continuous pulse-oximetry. Each of the 4 strategies will be performed for 45 minutes per strategy, interspersed with a 15-minute washout period of HFNC only. Participants will be randomized to the sequence of strategies for respiratory support.

A summary of the sequence of trial procedures is as follows:

1. Perform baseline measures.
2. Wait 5-10 minutes for recovery.
3. Initiate first random treatment assignment for up to 45 minutes.
4. HFNC-only washout for 15 minutes
5. Initiate second random treatment assignment for up to 45 minutes.
6. HFNC-only washout for 15 minutes
7. Initiate third random treatment assignment for up to 45 minutes.
8. HFNC-only washout for 15 minutes
9. Initiate fourth random treatment assignment for up to 45 minutes.
10. Return to usual care (HFNC only)

If a participant does not tolerate a given level of CNEP, the patient will be returned to HFNC for 5 minutes and then given the option to attempt that CNEP level again. If the patient declines reattempt or does not tolerate that CNEP level on reattempt, the HFNC-only washout will be instituted for 15 minutes before proceeding to the next protocol step.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Acute hypoxemic respiratory failure
* Non-cardiogenic airspace opacities on chest radiograph or computed tomography (CT) scan
* High-flow nasal cannula (flow ≥ 30 LPM) initiated within last 96 hours (4 days)
* FiO2 ≥ 40%
* SpO2 ≥ 92%

Exclusion Criteria:

* Do-not-intubate order
* Anatomical factor predisposing to poor fit of cuirass (e.g. severe kyphosis or scoliosis)
* Use of cuirass precluded, e.g. due to:

  * Clinically prescribed prone positioning
  * Tense ascites
  * Severe abdominal pain
  * Abdominal wound or surgery
  * Pregnancy
  * Agitated delirium
* Prior intubation during hospital stay
* Cardiogenic pulmonary edema
* Exacerbation of asthma or COPD
* Chronic lung disease, including:

  * Interstitial lung disease
  * Cystic fibrosis
  * Lung mass, lung cancer, or metastasis to the lung
  * Lung transplant recipient
  * Any disease that requires home oxygen
* Glasgow coma score \< 15
* Chest tube, pneumothorax, or pneumomediastinum
* Hemodynamic instability (mean arterial pressure \< 55 mmHg or norepinephrine-equivalent vasopressor requirement \> 0.1mcg/kg/min)
* Implantable electrical device (e.g. pacemaker, defibrillator, neurostimulator)
* Unreliable pulse-oximetry tracing
* Imminent intubation
* Anticipated lack of patient availability to complete study procedures (e.g. due to planned clinical procedure such as CT scan or dialysis during potential time of study)
* Attending physician refusal

Primary outcomes:
measure: Change from baseline in SpO2/FiO2
timeFrame: At the end of each treatment period, up to 45 minutes
Secondary outcomes:
measure: Change from baseline in Respiratory Rate
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in ROX Index
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in Transcutaneous Carbon Dioxide (CO2)
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in Heart Rate
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in Blood Pressure
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in Breathing Discomfort
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in Lightheadedness
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in Nausea
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in Skin Discomfort
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in Skin Erythema
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Tolerance of intervention period
timeFrame: For the duration of each treatment period, up to 45 minutes
measure: Proportion of time within 3 cm H2O of target CNEP level
timeFrame: For the duration of each treatment period, up to 45 minutes
measure: Proportion of time within 5 cm H2O of target CNEP level
timeFrame: For the duration of each treatment period, up to 45 minutes
Other outcomes:
measure: Change from baseline in other components of the Multidimensional Dyspnea Profile
timeFrame: At end of study
measure: Change from baseline in Tidal Volume
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in End-Expiratory Lung Volume
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in Minute Ventilation
timeFrame: At the end of each treatment period, up to 45 minutes
measure: Change from baseline in Anteroposterior Ventilation Ratio
timeFrame: At the end of each treatment period, up to 45 minutes
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jeremy Beitler, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: