Respiratory Failure Clinical Trial
Official title:
Eliminating Use of Non Depolarizing Neuromuscular Blocking Agents to Reduce Postoperative Pulmonary Complications: A Multi-center, Randomized Control Trial
Verified date | January 2023 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study to evaluate whether eliminating the use of non-depolarizing neuromuscular blocking agents (NMBA) for maintenance of general anesthesia reduces postoperative pulmonary complications in higher risk patients.
Status | Terminated |
Enrollment | 3 |
Est. completion date | December 19, 2022 |
Est. primary completion date | December 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - At least 18 years of age - Undergoing non-cardiac surgery under general anesthesia with an endotracheal tube - those at higher risk of developing postoperative pulmonary complications (internally validated risk prediction score of >=20) Exclusion Criteria: - Emergency surgery - Ambulatory (outpatient) surgery - Scheduled for elective postoperative ventilation - Planned return to operating room within 7 days of index procedure - Exposure to general anesthesia within 7 days prior to planned procedure - Requirement mechanical ventilation at baseline (not including stable use of CPAP/BiPAP) - Pregnant patients: as detected by patient self-reporting or diagnosed by preoperative pregnancy testing according to institutional policies at BIDMC and MGH - Allergy to either non-depolarizing muscle relaxants or sugammadex - Clinician refusal - Prisoner |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 30-Day Readmission Rates | How often patients had to be readmitted to the hospital within 30 days of discharge from hospital following index procedure. | 30 days | |
Other | Time to Post-Anesthesia Care Unit (PACU) Discharge Readiness | Time is takes for patients to be ready for discharge from PACU post operatively. | Day after surgery | |
Other | Cost of Anesthetic Medication | Cost of anesthetics used during surgical procedures in the study. | During the surgery | |
Other | Rate of Unplanned ICU Admission or Return to Operating Room | How often patients had either unanticipated ICU admissions or return to the operating room within 24 hours of the initial operation. | 24 hours | |
Other | Hospital Length of Stay | How much total time patients spent in the hospital after the operation. | Upto 30 days | |
Primary | Number of participants who either had postoperative pulmonary complications or died in hospital within 28 days of index procedure. | Composite of respiratory failure, suspected respiratory infection, aspiration pneumonia or pneumonitis, atelectasis, bronchospasm, reintubation and all cause in-hospital mortality | 28 Days | |
Secondary | Vasopressor Use Between Groups | Vasopressor equivalent dose | During the surgery | |
Secondary | Duration of Intraoperative Hypotension | Mean arterial pressure <55mmHg | During the surgery | |
Secondary | Surgeon's Assessment of surgical field | Was the operative condition optimal for the surgeon graded qualitatively using a numerical rating scale of 1-4. A score of 1 indicates excellent operating conditions whereas 4 indicates conditions unacceptable to the surgeon. | During the surgery |
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