Institutional Review Board, Hospital for Special Surgery
March 06, 2009
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
A number of factors surrounding spine surgery including mechanical ventilation may have an infrequently consequential, but measurable effect on the lung. Recent research suggests, that smaller breaths while on the breathing machine during surgery as compared to the traditional bigger breaths, may limit pulmonary inflammation in mechanically ventilated patients without preexisting lung injury. This hypothesis has not been tested in patients undergoing spine surgery, a group which may be prone to lung injury secondary to intraoperative ventilator and transfusion induced trauma and bony debris embolization.
If you decide to be in this study, the following routine and/or experimental procedures will be performed:
We will collect blood samples at the beginning of surgery (but after you are asleep), at 6 hours, and 12 hours thereafter. Urine will be collected from you before the start of surgery (after you are asleep), at 1 day and three days thereafter.
You will have a 50-50 chance (treatment or control) of receiving low tidal volumes during intraoperative ventilation throughout surgery. The method of treatment will be determined by a randomly picked opaque sealed envelope at the time point of enrollment by the individual enrolling the patient. Patients in the treatment group will be assigned to low tidal volumes during intraoperative ventilation. Control individuals will undergo surgery with traditional tidal volumes.
Your participation will involve a total of 5 study visits. Most visits are expected to last 3 minutes.
A total of 26 subjects will participate in this study at HSS.
• All non-pregnant patients between the ages of 18 and 85 undergoing posterior 2-4 level instrumentation spine surgery.
• Patients who are on immune-suppressants (including preoperative steroids, i.e. Decadron).
• Preoperative NSAIDs (i.e. ASA) use will not be an exclusion criterion.
• Renal failure with Creatinine >1.5
• Baseline pulmonary disease
• Recent ventilator support or surgery under general anesthesia
• Patients aged under 18 and over 85
Stavros G. Memtsoudis, MD