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Withdrawn No phase listed Observational

Assessing Respiratory Variability During Mechanical Ventilation in Acute Lung Injury (ALI)

ClinicalTrials.gov ID: NCT01083355

Public ClinicalTrials.gov record NCT01083355. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Assessing Respiratory Variability During Mechanical Ventilation in Acute Lung Injury

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Healthy biological systems are characterized by a normal range of "variability" in organ function. For example, many studies of heart rate clearly document that loss of the normal level of intrinsic, beat-to-beat variability in heart rate is associated with poor prognosis and early death. Unlike the heart, little is known about patterns of respiratory variability in illness. What is known is that, like the heart, healthy subjects have a specific range of variability in breath- to-breath depth and timing. Additionally, in animal models, ventilator strategies that re-introduce normal variability to the breathing pattern significantly reduce ventilator-associated lung injury. Critically ill patients requiring mechanical ventilation offer an opportunity to observe and analyze respiratory patterns in a completely non-invasive manner. Current mechanical ventilators produce real-time output of respiratory tracings that can analyzed for variability. The investigators propose to non-invasively record these tracings from patients ventilated in the intensive care units for mathematical variability analysis. The purpose of these pilot analyses are to: (1) demonstrate the range of respiratory variability present in the mechanically ve ventilated critically ill and (2) demonstrate the ventilator modality that delivers or permits the closest approximation to previously described beneficial or normal levels of variability. Future studies will use this pilot data in order to determine if the observed patterns of respiratory variability in mechanically ventilated critically ill subjects have prognostic or therapeutic implications.

Study identification

NCT ID
NCT01083355
Recruitment status
Withdrawn
Study type
Observational
Phase
Not listed
Lead sponsor
Boston Medical Center
Other
Enrollment
Not listed

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2010
Primary completion
Feb 29, 2016
Completion
Feb 29, 2016
Last update posted
Mar 29, 2016

2010 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Boston Medical Center Boston Massachusetts 02118

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01083355, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 29, 2016 · Synced Sep 6, 2026

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