Orthopedic SurgeryNCT06638658
Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions
An observational study of Orthopedic Surgery and Postoperative Complications, run by West China Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery, Postoperative Complications, High Altitude
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 31 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have lived in high-altitude regions scheduled for orthopedic surgery.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions: a Cohort Study.
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.
Read the 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.
- Keywords
- High-altitude population, Perioperative cohort, Orthopedic surgery
- Medical subject headings
- Postoperative Complications, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic surgery patients from high-altitude regions | high altitude patients Undergoing orthopedic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative venous thromboembolism
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.
Measured: During hospitalization
Secondary outcomes (7)
Postoperative venous thromboembolism
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.
Measured: Up to 2 weeks postoperatively
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.
Measured: During hospitalization
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.
Measured: During hospitalization
Postoperative nausea and vomiting
Nausea and vomiting
Measured: During hospitalization
The quality of postoperative recovery
Assessed using QoR-15 score at different time points after surgery
Measured: During hospitalization
Chronic pain after surgery
Assessed using NRS scale and BPI at different time points after surgery
Measured: Up to 1 year postoperatively
Postoperative quality of life assessment
Assessed using WHODAS2.0 scores at different time points after surgery
Measured: Up to 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
- Investigators
- Chunling Jiang, PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638658
- Sponsor's protocol ID
- 20241284
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions: a Cohort Study.
- ClinicalTrials.gov ID
- NCT06638658
- Acronym / sponsor ID
- 20241284
- Keywords
- High-altitude population, Perioperative cohort, Orthopedic surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthopedic surgery patients from high-altitude regions | – | –high altitude patients Undergoing orthopedic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have lived in high-altitude regions scheduled for orthopedic surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunling Jiang, PhD principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Surgery and Postoperative Complications, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunling Jiang, PhD (+86 02885422114, jiangchunling@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative venous thromboembolism (time frame: During hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.