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Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions

Observational Orthopedic Surgery Postoperative Complications High Altitude

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Orthopedic Surgery, Postoperative Complications, High Altitude. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions: a Cohort Study.

Overview

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.

Detailed description

Prolonged exposure to hypoxic and low-pressure environments leads to structural remodeling and functional abnormalities in the cardiovascular, respiratory, and hematological systems of high-altitude populations. This elevates the risk of postoperative complications, particularly in patients undergoing orthopedic surgery, significantly impacting their recovery and quality of life. This study will focus on orthopedic surgery patients from high-altitude regions. Using smart wearable devices and other monitoring tools, comprehensive perioperative dynamic data of participants, including heart rate, heart rate variability, oxygen saturation, respiratory rate, sleep quality, activity levels, stress index, and other relevant indicators will be collected. Regular follow-ups will be conducted to evaluate postoperative recovery and monitor the incidence of perioperative complications. Additionally, perioperative data such as electronic medical records, laboratory test results, ECG waveforms, echocardiography, chest CT images, and other pertinent records will be also collected. Through that, this study aims to establish a follow-up cohort of orthopedic surgery patients from high-altitude regions.

Primary outcome measures

  • Postoperative venous thromboembolism [Time frame: During hospitalization]
Secondary outcome measures (7)
  • Postoperative venous thromboembolism [Time frame: Up to 2 weeks postoperatively]
  • A composite of postoperative pulmonary complications [Time frame: During hospitalization]
  • Postoperative major adverse cardiovascular events [Time frame: During hospitalization]
  • Postoperative nausea and vomiting [Time frame: During hospitalization]
  • The quality of postoperative recovery [Time frame: During hospitalization]
  • Chronic pain after surgery [Time frame: Up to 1 year postoperatively]
  • Postoperative quality of life assessment [Time frame: Up to 1 year postoperatively]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06638658 · 20241284

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗