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NCT Number: NCT06638658

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Postoperative venous thromboembolism

    Time frame: During hospitalization

    Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.

Secondary outcomes

  1. Postoperative venous thromboembolism

    Time frame: Up to 2 weeks postoperatively

    Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.

  2. A composite of postoperative pulmonary complications

    Time frame: During hospitalization

    Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia.

  3. Postoperative major adverse cardiovascular events

    Time frame: During hospitalization

    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.

  4. Postoperative nausea and vomiting

    Time frame: During hospitalization

    Nausea and vomiting

  5. The quality of postoperative recovery

    Time frame: During hospitalization

    Assessed using QoR-15 score at different time points after surgery

  6. Chronic pain after surgery

    Time frame: Up to 1 year postoperatively

    Assessed using NRS scale and BPI at different time points after surgery

  7. Postoperative quality of life assessment

    Time frame: Up to 1 year postoperatively

    Assessed using WHODAS2.0 scores at different time points after surgery

Other outcomes

  1. Pain scores of movement-evoked pain

    Time frame: During hospitalization

    Assessed using NRS scale and BPI at different time points after surgery

  2. Pain scores at rest

    Time frame: During hospitalization

    Using NRS scale and BPI at different time points after surgery

  3. Surgical site infection

    Time frame: During hospitalization

    Defined according to the European Perioperative Clinical Outcome (EPCO) criteria

  4. Time of Bowel function recovery

    Time frame: During hospitalization

    Defined as time to first defecation or flatus

  5. Sleep quality after surgery

    Time frame: Up to 1 year postoperatively

    Assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Morningness-Eveningness Questionnaire (MEQ) at different time points after surgery

  6. Postoperative anxiety assessment

    Time frame: Up to 1 year postoperatively

    Assessed using GAD-7 scores at different time points after surgery

  7. Postoperative depression assessment

    Time frame: Up to 1 year postoperatively

    Assessed using PHQ-9 scores at different time points after surgery

  8. Postoperative cognitive function assessment

    Time frame: Up to 1 year postoperatively

    Assessed using AD-8 and three-word recall test scores at different time points after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Chunling Jiang, PhD

CONTACT

[email protected]

+86 02885422114

Fengming Luo, phD

CONTACT

[email protected]

+86 85423593

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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