Mixed reality-assisted versus landmark-guided spinal puncture in elderly patients: protocol for a stratified randomized controlled trial.

Autor: Gao L; Department of Anesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China., Zhang H; Department of Anesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China., Xu Y; Department of Anesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China., Dong Y; Department of Anesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China., Sheng L; Department of Urology, Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China., Fan Y; Department of Orthopedics, Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China., Qin C; Department of Pain Management, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. drqch88@163.com., Gu W; Department of Anesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China. hdmz0800@163.com.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Nov 19; Vol. 25 (1), pp. 780. Date of Electronic Publication: 2024 Nov 19.
DOI: 10.1186/s13063-024-08628-2
Abstrakt: Background: Performing spinal anesthesia in elderly patients with spine degeneration is challenging for novice practitioners. This stratified randomized controlled trial aims to compare the effectiveness of mixed reality-assisted spinal puncture (MRasp) with that of landmark-guided spinal puncture (LGsp) performed by novice practitioners in elderly patients.
Methods: This prospective, single-center, stratified, blocked, parallel randomized controlled trial will include 168 patients (aged ≥ 65 years) scheduled for elective surgery involving spinal anesthesia. All spinal punctures will be performed by anesthesiology interns and residents trained at Huadong Hospital. Patients will be randomly assigned to the MRasp group (n = 84) or the LGsp group (n = 84). Based on each intern/resident's experience in spinal puncture, participants will be stratified into three clusters: the primary group, intermediate group, and advanced group. The primary outcome will be the comparison of the rate of successful first-attempt needle insertion between the MRasp group and the LGsp group. Secondary outcomes will include the number of needle insertion attempts, the number of redirection attempts, the number of passes, the rate of successful first needle pass, the spinal puncture time, the total procedure time, and the incidence of perioperative complications. A stratified subgroup analysis will also be conducted for interns/residents at different experience levels.
Discussion: The findings from this trial establish the effectiveness of MRasp by novice practitioners in elderly patients. This trial may provide experimental evidence for exploring an effective visualization technology to assist in spinal puncture.
Trial Registration: Chinese Clinical Trials Registry ChiCTR2300075291. Registered on August 31, 2023. https://www.chictr.org.cn/bin/project/edit?pid=189622 .
Competing Interests: Declarations Ethics approval and consent to participate {24} Ethics approval has been obtained from the Medical Ethics Committee of Huadong Hospital affiliated to Fudan University, China (approval no. 20220140, Chairperson Prof Yinghao Sha; date of approval, 1st December 2022) (Additional file 2) and conforms to the principles of the Helsinki Declaration. The investigators will obtain written informed consent (available from the corresponding author) from all participants (Additional file 3). Consent for publication {32} If images of an individual person are used for publication of the trial, written consent will be obtained from that person for the publication of these details. Competing interests {28} The authors declare that they have no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
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