Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CT for Personalized Mechanical Ventilation

NCT05977153

Ventilator-Induced Lung Injury Sepsis Syndrome Mechanical Ventilation Complication

ACTIVE_NOT_RECRUITING NA

Impact of Negative Pressure Ventilation in Patients Hospitalized with Acute Hypercapnic Respiratory Failure

NCT06108284

Acute Hypercapnic Respiratory Failure

RECRUITING NA

Effects on Experimental Dyspnea of High Flow Nasal Cannula

NCT03469037

Dyspnea Healthy Volunteers

COMPLETED NA

Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

NCT05784636

Hypoxemia

UNKNOWN NA

Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure

NCT04408222

Oxygen Deficiency Coronavirus Infection

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Hypoxemic Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HFNC only

Group Type ACTIVE_COMPARATOR

HFNC only

Intervention Type DEVICE

HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

HFNC + CNEP10

Group Type EXPERIMENTAL

HFNC + CNEP10

Intervention Type DEVICE

HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

HFNC + CNEP20

Group Type EXPERIMENTAL

HFNC + CNEP20

Intervention Type DEVICE

HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

HFNC + CNEP30

Group Type EXPERIMENTAL

HFNC + CNEP30

Intervention Type DEVICE

HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HFNC only

HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

Intervention Type DEVICE

HFNC + CNEP10

HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

Intervention Type DEVICE

HFNC + CNEP20

HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

Intervention Type DEVICE

HFNC + CNEP30

HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No