Acute Respiratory Distress Syndrome
Conditions
Keywords
Intraoperative protective ventilation strategies
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.
Interventions
OTHERVentilator settings
Active Comparison of three different parameters of ventilator settings. Results of arterial blood gases and cytokine levels.
Sponsors
University of Medicine and Dentistry of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cytokine levels in serum and bronchial aspirate | during the operative procedure |
Secondary
| Measure | Time frame |
|---|---|
| arterial blood gases | during the operative procedure |
| subject post-operative outcome:mortality, pulmonary complications, major cardiac morbidity, LOS, readmission | wothin 30 days of surgery |
Countries
United States
Outcome results
None listed