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NCT00538161 · ClinicalTrials.gov registry record · NA

Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient

A NA study, sponsored by Beth Israel Deaconess Medical Center.

Completed
Registry status
NA
Development phase
150
Enrollment target

NCT00538161: Completed NA study, sponsored by Beth Israel Deaconess Medical Center.

NCT00538161 is a NA study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00538161, a NA study, has completed, sponsored by Beth Israel Deaconess Medical Center.

COMPLETED
Registry status
NA
Development phase
150 participants
Enrollment target

Study Summary

We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury. In this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine if there is a role for low tidal volume ventilation in the operating room. We will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ARDS.

Interventions

  • OTHER Ventilation strategy

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2007-10
Est. Completion 2011-01
Phase NA

What the finished NCT00538161 record still lists

NCT00538161 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 1 intervention - of which Ventilation strategy is the first listed.

NCT00538161 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00538161 about?

NCT00538161 is a clinical study titled "Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient". We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Institution of low tidal volume ventilation in the operating room may reduce the release o...

What is the current status of trial NCT00538161?

This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2007-10. Estimated completion is 2011-01.

What interventions are being tested in trial NCT00538161?

The interventions under investigation include: Ventilation strategy (OTHER).

Who is sponsoring clinical trial NCT00538161?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00538161's enrollment target sits among peer trials

150 661st of 2000 higher than 1,299 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00538161, the US trial registry maintained by the National Library of Medicine. NCT00538161 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.