Orthopedic Surgery Clinical Trial
Official title:
Ventilation Strategy During General Anesthesia for Orthopedic Surgery
Verified date | May 2024 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective is to determine the optimal intraoperative ventilation strategy among the chosen tidal volume and positive end-expiratory pressure (PEEP) levels, and standardize it in an enhanced recovery pathway for orthopedic surgical patients. In particular, we propose to determine which combination of intraoperative tidal volume and positive end-expiratory pressure is best for patients having elective orthopedic surgery.
Status | Completed |
Enrollment | 2887 |
Est. completion date | November 10, 2020 |
Est. primary completion date | November 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Surgery in orthopedic operating rooms 32-37 - General anesthesia with endotracheal intubation. Exclusion Criteria: - Non-orthopedic procedures; - Intubation before induction of anesthesia. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory outcome: | Time from extubation to first oxygen saturation on ambient air breathing. | After surgery until discharged from the hospital | |
Other | Exploratory objective: | Intraoperative estimated blood loss and perioperative transfusions. | from 2 to 5 days | |
Primary | Time-weighted average SaO2/FiO2 ratio in the postanesthesia care unit (PACU) | Arterial oxygen saturation (SaO2) is monitored continuously in in the PACU by pulse oximetry.inspired oxygen fraction (FiO2) will be estimated from the type of device and the oxygen flow rate, using the following conversion table below. We will assume that the FiO2 remains at the same level until the time of next record. | After surgery until discharged from PACU or up to 90 minutes | |
Secondary | Composite of serious postoperative pulmonary complications | Postoperative diagnoses will be collected from electronic medical records of patients. Individual chart reviews (blinded to ventilation management) will confirm that terms of the composite are met will be performed. | After surgery from 2 to 5 days | |
Secondary | Oxygenation in ward, defined as SaO2/FIO2 ratio | Oxygen administration and SaO2 are normally recorded at 4-hour intervals on surgical wards. The overall of SaO2/FIO2 will be compared among different ventilation strategies. | After surgery from 2 to 5 days | |
Secondary | Length of postoperative hospital stay | The number of hospitalization days will be recorded | from 2 to 5 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
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