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

This study has suspended participant recruitment.
(PI has left the UMDNJ but may resume the study in her new place of employment.)
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01003730
First received: October 21, 2009
Last updated: January 14, 2011
Last verified: January 2011

October 21, 2009
January 14, 2011
March 2009
December 2012   (final data collection date for primary outcome measure)
cytokine levels in serum and bronchial aspirate [ Time Frame: during the operative procedure ] [ Designated as safety issue: No ]
cytokine levels in bronchial aspirate [ Time Frame: during the operative procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01003730 on ClinicalTrials.gov Archive Site
  • arterial blood gases [ Time Frame: during the operative procedure ] [ Designated as safety issue: Yes ]
  • subject post-operative outcome:mortality, pulmonary complications, major cardiac morbidity, LOS, readmission [ Time Frame: wothin 30 days of surgery ] [ Designated as safety issue: No ]
arterial blood gases [ Time Frame: during the operative procedure ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
The Effects of Different Ventilator Strategies on Inflammation and Injury in Normal Lungs
The Effects of Different Ventilator Strategies on Inflammation and Injury in Normal Lungs

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
Other: Ventilator settings
Active Comparison of three different parameters of ventilator settings. Results of arterial blood gases and cytokine levels.
  • Active Comparator: 1
    High tidal volume (15mL/kg PBW0 with low PEEP (3cm H2O
    Intervention: Other: Ventilator settings
  • Active Comparator: 2
    Low tidal volume (6mL/kg PBW) and high PEEP (3cm H2O)
    Intervention: Other: Ventilator settings
  • Active Comparator: 3
    low tidal volume (6mL/kg PBW) and high PEEP (10cm H2O)
    Intervention: Other: Ventilator settings

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
198
April 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective surgery under general anesthesia expected to take 4 hours or more positioned supine for surgery

Exclusion Criteria:

  • Subjects who have HIV or who have had Radiation or chemotherapy for cancer
  • Subjects undergoing surgery on chest or lings
  • Subjects who have obstructive sleep apnea (OSA), asthma, tuberculosis, chronic obstructive pulmonary disease
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01003730
0120080132
No
Zoulfra Nisnevitch, MD, University of Medicine & Dentistry of New Jersey
University of Medicine and Dentistry of New Jersey
Not Provided
Principal Investigator: Zoulfra Nisnevitch, MD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP