Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
This study will focus on orthopedic surgery patients from high-altitude regions, utilizing smart wearables and monitoring tools to gather perioperative data, including heart rate, oxygen saturation, sleep quality, stress levels, and other relevant metrics. Regular follow-ups will assess recovery and complications, in addition to collecting medical records, lab results, imaging data, and other pertinent records. The ultimate goal is to establish a comprehensive follow-up cohort of orthopedic surgery patients from high-altitude areas.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years;
ASA classification I-III;
Patients who have lived at an altitude above 2500 meters for more than 6 months ;
Patients scheduled for elective orthopedic surgery.
Disqualifiers
Urgent or emergent surgery;
Expected hospital stay < 48 hours;
Inability to provide informed consent；
Patients who have been out of high-altitude regions for over three months.
Trial population
Patients who have lived in high-altitude regions scheduled for orthopedic surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: Orthopedic surgery patients from high-altitude regions
Trial outcomes
Primary outcomes
1
Postoperative venous thromboembolism
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.
Time frame
During hospitalizationSecondary outcomes
1
Postoperative venous thromboembolism
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.
Time frame
Up to 2 weeks postoperatively2
A composite of postoperative pulmonary complications
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia.
Time frame
During hospitalization3
Postoperative major adverse cardiovascular events
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmias, angina, et al.
Time frame
During hospitalization4
Postoperative nausea and vomiting
Nausea and vomiting
Time frame
During hospitalizationOther outcomes
1
Pain scores of movement-evoked pain
Assessed using NRS scale and BPI at different time points after surgery
Time frame
During hospitalization2
Pain scores at rest
Using NRS scale and BPI at different time points after surgery
Time frame
During hospitalization3
Surgical site infection
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria
Time frame
During hospitalization4
Time of Bowel function recovery
Defined as time to first defecation or flatus
Time frame
During hospitalizationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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