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Mixed reality-assisted Versus Landmark-guided spinal puncture in elderly patients: a randomized controlled pilot study

Mixed reality-assisted Versus Landmark-guided spinal puncture in elderly patients: a randomized controlled pilot study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068520
Enrollment
Unknown
Registered
2023-02-22
Start date
2023-02-22
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal puncture

Interventions

Mixed reality-assisted group:spinal puncture with an optimal pathway designed by mixed reality
Landmark-guided group:conventional spinal puncture

Sponsors

Huadong Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 65 years or older; 2. Patients undergoing surgery with spinal anesthesia; 3. ASA grade I-II.

Exclusion criteria

Exclusion criteria: 1. Patients with abnormal coagulation function or are taking anticoagulant drugs; 2. Patients with skin infection at the puncture site; 3. Patients with neurological diseases or increased intracranial pressure; 4. Patients with chronic lumbocrural pain or history of lumbar trauma or surgery; 5. Patients with severe hypovolemia; 6. Patients who unable to cooperate with puncture; 7. Patients who refuse to participate in the study.

Design outcomes

Primary

MeasureTime frame
First needle insertion success rate;Persistent pain at the puncture site after surgery;

Secondary

MeasureTime frame
Number of needle insertion attempts;Number of redirection attempts;Number of passes;First needle pass success rate;Time taken to perform the spinal puncture;Total procedure time;Conversion to paramedian approach;Conversion to different lumbar segment;Conversion to different anesthesiologist;

Countries

China

Contacts

Public ContactGao Lei

Huadong Hospital affiliated to Fudan University

highlay@163.com+86 13817006581

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026