- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06404892
ARISCAT, ASA and LAS VEGAS Risk Scores and the Incidence of Postoperative Pulmonary Complications in Thoracic Surgery
ARISCAT, ASA and LAS VEGAS Risk Scores and the Incidence of Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery With Single-lung Ventilation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pulmonary complications (PPC) are among the main complications after the anesthetic-surgical procedure; CPP prolong hospital stay and increase costs in health systems. It can be said that thoracic surgery results in impaired respiratory function in the postoperatively, due to the decrease in lung volumes and capacities (the vital capacity decreases by approximately 50-60% and functional residual capacity decreases by approximately 30% in the first 24 hours after surgery) diaphragm dysfunction, gas exchange impaired, cough and ineffective mucociliary clearance.
Thus, our hypothesis is that the application of preoperative risk scores normally used for non-cardiac and non-thoracic surgeries may be effective in the predictability of the occurrence of CPP in patients undergoing ventilation single-lung. In this study, we will prospectively evaluate the performance of ASA, ARISCAT and LAS VEGAS scores in predicting patients who present with CPP in thoracic surgeries using single-lung ventilation. We will also analyze other potential patient risk factors as well as complications presented.
This is a prospective observational study. Data will be collected using a standardized form at the surgical center of Hospital Nossa Senhora da Conceição and at the Hospital de Clínicas de Porto Alegre, evaluated preoperatively, intraoperatively and postoperatively. Direct observation and recording of variables studied by the anesthesiology medical team of both hospitals, previously trained and supervised by the main researcher. Patients will be monitored until hospital discharge or up to a maximum period of 30 days of hospital admission.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Andre P Schmidt, MD
- Phone Number: 5551996412212
- Email: aschmidt@ghc.com.br
Study Contact Backup
- Name: Rejane Piantamar
- Phone Number: 555133572419
- Email: prejane@ghc.com.br
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90035903
- Recruiting
- HCPA
-
Contact:
- Andre P Schmidt, Md, PhD
- Phone Number: 5551996412212
- Email: apschmidt@hcpa.edu.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients undergoing any thoracic procedure associated with intraoperative single-lung ventilation.
Exclusion Criteria:
- Patients undergoing cardiac surgery, pregnant women, patient refusal, contraindications to proposed surgical, anesthetic or analgesic techniques, sepsis, psychiatric illness, uncontrolled endocrine, kidney or liver disease and coagulopathies.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Patients undergoing thoracic surgery and single-lung ventilation.
|
Patients undergoing thoracic surgery and intraoperative single-lung ventilation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pulmonary complications
Time Frame: up to 30 days after surgery
|
Incidence of composite pulmonary complications after surgery
|
up to 30 days after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andre P Schmidt, MD, Hospital Nossa Senhora Da Conceição
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 75871723.4.0000.5530
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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