An observational study in Respiratory Failure, Acute Respiratory Failure Requiring Reintubation and Pulmonary Edema, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-21.
Sponsored by Massachusetts General Hospital · Observational
Intraoperative intravenous fluid management practice varies greatly between anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity. Postoperative respiratory complications are associated with increased morbidity, mortality and hospital costs. The literature shows conflicting data regarding intraoperative fluid resuscitation volume. No large-scale studies have focused on intraoperative fluid management and postoperative respiratory dysfunction.
Hypotheses:
Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of 30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation, atelectasis, acute kidney injury and peri-extubation oxygen desaturation.
1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.
This study's enrollment of 104,000 is above the median of 100 across 556 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
All surgical patients aged 18 upwards receiving general anesthesia at Massachusetts General Hospital between January 2007 and November 2012
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Exclusion Criteria:
Mortality
Mortality within 30 days of surgery
Time frame: within 30 days after surgery
Postoperative pulmonary complications
The incidence of a diagnosis of pneumonia, respiratory failure, atelectasis or pulmonary edema within 3 days after extubation in the operating room. Cases where these diagnoses were present on the day before surgery were not counted.
Time frame: 3 days after surgery
Acute Kidney Injury
A Creatinine increase of \>0.3mg/dl or 50% from baseline (Creatinine value closest recorded to surgery but within 30 days of surgery) to maximum value measured within 48 hours postoperatively or an ICD-9 diagnosis of AKI within 7 days of surgery but not within 30 days prior to surgery
Time frame: within 48 hours of surgery
Post-extubation oxygen desaturation
One or more minutes with a blood oxygen saturation below 90% during the first ten minutes after extubation
Time frame: within the first 10 minutes after extubation
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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