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
  Purpose

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.


Condition Intervention
Acute Respiratory Distress Syndrome
Other: Ventilator settings

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effects of Different Ventilator Strategies on Inflammation and Injury in Normal Lungs

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • cytokine levels in serum and bronchial aspirate [ Time Frame: during the operative procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 198
Study Start Date: March 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
High tidal volume (15mL/kg PBW0 with low PEEP (3cm H2O
Other: Ventilator settings
Active Comparison of three different parameters of ventilator settings. Results of arterial blood gases and cytokine levels.
Active Comparator: 2
Low tidal volume (6mL/kg PBW) and high PEEP (3cm H2O)
Other: Ventilator settings
Active Comparison of three different parameters of ventilator settings. Results of arterial blood gases and cytokine levels.
Active Comparator: 3
low tidal volume (6mL/kg PBW) and high PEEP (10cm H2O)
Other: Ventilator settings
Active Comparison of three different parameters of ventilator settings. Results of arterial blood gases and cytokine levels.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003730

Locations
United States, New Jersey
UMDNJ/University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Zoulfra Nisnevitch, MD Rutgers, The State University of New Jersey
  More Information

Publications:
Responsible Party: Zoulfra Nisnevitch, MD, University of Medicine & Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT01003730     History of Changes
Other Study ID Numbers: 0120080132
Study First Received: October 21, 2009
Last Updated: January 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Intraoperative protective ventilation strategies

Additional relevant MeSH terms:
Inflammation
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on September 18, 2014