Validation of a Simple Approach to Estimate Alveolar Recruitability in ARDS Patients

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

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-12-31

Brief Summary

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

This study will test the validity of a new approach to assess alveolar recruitability at the bedside in comparison to direct measurements of lung volume and derecruitment.

Related Clinical Trials

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

Maneuver for Evaluating the Potential Recruitability of the Pulmonary Parenchyme in Patients With ARDS

NCT04387669

Acute Respiratory Distress Syndrome

UNKNOWN

Comparison of Two Methods to Estimate the Lung Recruitment

NCT00759590

Acute Respiratory Distress Syndrome Acute Lung Injury

UNKNOWN

How to Predict Lung Recruitment at the Bedside in Patients Affected by Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)

NCT00682942

Acute Respiratory Distress Syndrome

COMPLETED

Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients

NCT03281473

Acute Respiratory Distress Syndrome

UNKNOWN NA

Incidence of Dyssynchronies in Early ARDS

NCT03447288

ARDS Acute Hypoxemic Respiratory Failure

UNKNOWN

Detailed Description

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

Background: Acute respiratory distress syndrome (ARDS) is characterized by a major loss of lung volume due to alveolar flooding, atelectasis and consolidation\[1\]. Positive end-expiratory pressure (PEEP) is applied to recruit non-aerated or poorly aerated lung tissue, and thus may improve gas exchange in patients with ARDS\[2\]. However, PEEP may also be harmful by overdistending the previously open lung tissue. The potential effectiveness and benefit of high PEEP levels depends on the patient's recruitability. Previous techniques for assessing recruitability are usually reserved for clinical research (computed tomography, multiple pressure-volume curves)\[3-4\] or need special equipment. A simple, feasible bedside method to assess the individual needs for PEEP in terms of recruitability seem essential to improve the prognosis of this syndrome. The investigators therefore propose a simplified approach derived from our previous study\[5\] to estimate alveolar recruitability at the bedside.

Objectives: The major aim is to test the hypothesis that this simplified approach is a valid method for assessing alveolar derecruitment at the bedside in comparison to direct measurements of lung volume and derecruitment.

Methods: This physiological study will enroll 30 patients from the three Intensive Care Units at St. Michael's Hospital in two years. All patients will be passively ventilated at two PEEP levels (15 cmH2O and 5 cmH2O) and the plateau pressure will be limited to less than 35 cmH2O. Respiratory mechanics, lung volumes (using the nitrogen washout/washin technique), quasi-static Pressure-Volume curves, lung ultrasound, and arterial blood gases will be assessed at each PEEP level. In patients who already have an esophageal catheter in place, Pes will also be measured.

Data Analysis: The primary endpoint is the correlation and bias between the Vder estimated by our approach and the one measured by the multiple P-V curves technique through paired tests, correlations and Bland and Altman analysis

Conditions

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

Acute Respiratory Distress Syndrome

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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

Inclusion Criteria

* Patients \> 16 years of age
* Moderate-to-severe ARDS as per the Berlin definition (Partial pressure of oxygen (PaO2)/Fraction of inspired oxygen (FiO2) \< 200 mmHg) and within 10 days of onset
* Receiving assist/control mechanical ventilation (volume or pressure) with continuous sedation and an established arterial line

Exclusion Criteria

* Pneumothorax with fistula or likely to require a chest tube
* Severe hemodynamic instability (\> 30% increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min)
* PaO2/FiO2 \< 80 mmHg
* Severe or very severe Chronic Obstructive Pulmonary Disease according to the GOLD criteria (stage III: Forced expiratory volume at one second (FEV1) 30-50% predicted; stage IV: FEV1 \< 30% predicted)
* Known or highly suspected elevated intracranial pressure (\> 18 mmHg)

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No