跳至主要内容
临床试验/NCT06661525
NCT06661525Enrolling By Invitation不适用

Advanced Optical Monitoring of Free Tissue Transfer Hemodynamics

University of British Columbia4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
4
主要终点
Establish a baseline Total Oxygenation Index (TOI) to measure NIRS on FTT cases

研究概览

简要总结

Free tissue transfer (FTT) is a surgical procedure for repairing cancer resection wounds. Free tissue transfer usually involves taking skin from one area of the body (e.g. leg) and transplanting it to the surgically created wound (e.g. neck wound). Due to problems with anastomosis, the transplanted skin can die. If the poor blood supply can be detected early, transplanted skin can be saved by taking patients back to the operating room. The investigators propose to improve the design and test a novel, non-invasive monitoring system specifically for head and neck surgeries for early detection of poor blood supply to the transplanted tissue after FTT surgery.

详细描述

PURPOSE: To improve the design and evaluation of a novel spatially resolved near-infrared spectroscopy (NIRS) system customized for continuous postoperative free tissue transfer (FTT) monitoring and to make this system commercially available.

HYPOTHESIS: The novel NIRS device is capable of monitoring FTT reconstruction continuously for 72 hours after surgery with minimal interference to patient care, minimal discomfort to the patient, and minimal interference with clinical assessment.

JUSTIFICATION FOR THE STUDY: FTT consists of transplanting skin, muscle or bone along with its feeding blood vessels from one body site to reconstruct a defect created by removing cancerous tumours or traumatic injury at a separate site. The key to the survival of the transplanted tissue is the meticulously created microvascular anastomosis between the blood vessels of the transplanted tissue and the blood vessels of the recipient site. Microsurgical techniques have been refined over time to maintain the patency of the anastomosed blood vessels. Nevertheless, the current FTT failure rate is between 1 and 10%.

When FTT failure occurs, it is a devastating experience for the patient and the surgical team. The patient has to be urgently brought to the operating room for an attempted salvage of the microvascular anastomosis. In the event of unsuccessful salvage, the patient has to undergo multiple surgeries that compound the associated morbidity, prolong hospital stay, and increase health care costs. Early detection of vascular compromise is essential for increasing the odds of successful salvage. Thus, the methods used to monitor the FTT vascular status are critical and have received much attention in the literature. Clinical examination remains the gold standard and the most popular method of monitoring FTT viability. The two downsides of clinical examinations are the requirement for personnel trained and experienced in FTT monitoring and the inability to provide reliable continuous monitoring. Therefore recognition of FTT compromise is often delayed significantly compromising successful surgical salvage attempts.

Recently, NIRS has been recognized as the technology with the most potential to address the problems seen with FTT clinical monitoring. NIRS is a non-invasive technique that passes near-infrared light (600-1000 nm) through the tissues at a depth of 10 to 20 mm. Calculating the amount of absorbed light allows real-time measurements of oxygenated, deoxygenated, and total hemoglobin concentrations. Therefore, an abnormality of tissue perfusion and oxygenation can then be detected instantaneously and confirmed clinically. Reducing the time from detection of vascular compromise to the attempted FTT rescue in the operating room decreases the ischemia time and increases the FTT salvage rate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 60 patients undergoing a variety of free tissue transfer for head and neck cancer. The result of the reconstruction should be easily visible to the clinicians.
  • Age of 18 years old or older

排除标准

  • Serious medical condition or other disease which occurs at the same time
  • Metastatic disease
  • Pregnant or nursing

研究组 & 干预措施

Participants

Experimental

Data collection from Participants and evaluate their feedback by filling a questioner

干预措施: Free Flap NIRS (Device)

Care providers

Active Comparator

Care providers will provide their feedback via questioner

干预措施: Free Flap NIRS (Device)

结局指标

主要结局

Establish a baseline Total Oxygenation Index (TOI) to measure NIRS on FTT cases

时间窗: Up to 36 months

The total oxygenation index (TOI) measurements will be used to establish a TOI baseline for Free Tissue Transfer (FTT) and to calibrate and tune the FTT-system

Enhance the design and accuracy of the FTT- NIRS sensor based on patient and clinicians feedback

时间窗: 24 months

The data collected will be used to enhance the design and accuracy of the next generation of NIRS sensors based on the feedback provided by the patient and clinician

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donald W. Anderson

Principal Investigator

University of British Columbia

研究点 (4)

Loading locations...

相似试验