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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ventilator settings
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Intraoperative protective ventilation strategies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMDNJ/University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

High tidal volume (15mL/kg PBW0 with low PEEP (3cm H2O

Low tidal volume (6mL/kg PBW) and high PEEP (3cm H2O)

low tidal volume (6mL/kg PBW) and high PEEP (10cm H2O)

Outcomes

Primary Outcome Measures

cytokine levels in serum and bronchial aspirate

Secondary Outcome Measures

arterial blood gases
subject post-operative outcome:mortality, pulmonary complications, major cardiac morbidity, LOS, readmission

Full Information

First Posted
October 21, 2009
Last Updated
May 1, 2015
Sponsor
University of Medicine and Dentistry of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01003730
Brief Title
The Effects of Different Ventilator Strategies on Inflammation and Injury in Normal Lungs
Official Title
The Effects of Different Ventilator Strategies on Inflammation and Injury in Normal Lungs
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
PI has left the UMDNJ but may resume the study in her new place of employment.
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Intraoperative protective ventilation strategies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
High tidal volume (15mL/kg PBW0 with low PEEP (3cm H2O
Arm Title
2
Arm Type
Active Comparator
Arm Description
Low tidal volume (6mL/kg PBW) and high PEEP (3cm H2O)
Arm Title
3
Arm Type
Active Comparator
Arm Description
low tidal volume (6mL/kg PBW) and high PEEP (10cm H2O)
Intervention Type
Other
Intervention Name(s)
Ventilator settings
Intervention Description
Active Comparison of three different parameters of ventilator settings. Results of arterial blood gases and cytokine levels.
Primary Outcome Measure Information:
Title
cytokine levels in serum and bronchial aspirate
Time Frame
during the operative procedure
Secondary Outcome Measure Information:
Title
arterial blood gases
Time Frame
during the operative procedure
Title
subject post-operative outcome:mortality, pulmonary complications, major cardiac morbidity, LOS, readmission
Time Frame
wothin 30 days of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellise Delphin, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ/University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11149435
Citation
Wrigge H, Zinserling J, Stuber F, von Spiegel T, Hering R, Wetegrove S, Hoeft A, Putensen C. Effects of mechanical ventilation on release of cytokines into systemic circulation in patients with normal pulmonary function. Anesthesiology. 2000 Dec;93(6):1413-7. doi: 10.1097/00000542-200012000-00012.
Results Reference
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PubMed Identifier
16132888
Citation
Wrigge H, Uhlig U, Baumgarten G, Menzenbach J, Zinserling J, Ernst M, Dromann D, Welz A, Uhlig S, Putensen C. Mechanical ventilation strategies and inflammatory responses to cardiac surgery: a prospective randomized clinical trial. Intensive Care Med. 2005 Oct;31(10):1379-87. doi: 10.1007/s00134-005-2767-1. Epub 2005 Aug 17.
Results Reference
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The Effects of Different Ventilator Strategies on Inflammation and Injury in Normal Lungs

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