Clinical Trials Directory

Trials / Terminated

TerminatedNCT01003730

The Effects of Different Ventilator Strategies on Inflammation and Injury in Normal Lungs

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
1 (actual)
Sponsor
University of Medicine and Dentistry of New Jersey · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This research is being done to determine if there is a way the investigators can improve the techniques that they use to assist patients with their breathing during surgery. The majority of surgeries require patients to concurrently undergo general anesthesia. This usually includes a breathing tube and a machine that breathes for the patient during the duration of the surgery. The doctors would like to investigate the effects of this type of anesthesia to healthy adult patients and whether they can improve the way they give general anesthesia to patients. The investigators plan to ask approximately 200 patients to participate. If the patients decide to participate in the study,some additions will be made to the standard anesthetic care they receive. The patients will additionally be monitored for adequate oxygenation in their blood as well as level of inflammation in their blood and lungs. The patients' breathing tube will be bathed with warm normal saline and suctioned twice during the operation. When these procedures are done the patients will be asleep and not be aware of what is happening.

Detailed description

The ability to provide mechanical ventilation that will not injure and may protect normal lungs during major surgical procedures of long duration may improve postoperative outcomes and decrease morbidity and mortality. The aim of the current study was to identify ventilator strategies that are less damaging to normal lungs. The investigators plan to compare three ventilation strategies commonly utilized in the operating room in normal lungs. One group will be ventilated with high tidal volume (15 mL/kg PBW) and low PEEP (3 cm H2O), another group ventilated with low tidal volume (6 mL/kg PBW) and low PEEP (3 cm H2O) and the final group ventilated with low tidal volume (6 mL/kg PBW) and high PEEP (10 cm H2O). This study will show the effects of these commonly used methods of ventilation on pulmonary mechanics, systemic and pulmonary inflammatory markers and outcomes in patients with normal lungs undergoing surgery of long duration.

Conditions

Interventions

TypeNameDescription
OTHERVentilator settingsActive Comparison of three different parameters of ventilator settings. Results of arterial blood gases and cytokine levels.

Timeline

Start date
2009-03-01
Primary completion
2010-03-01
Completion
2010-03-01
First posted
2009-10-29
Last updated
2015-05-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01003730. Inclusion in this directory is not an endorsement.