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临床试验/NCT04462497
NCT04462497招募中不适用

Chest-Up: Obtaining Safe Positioning for Thoracic Surgery

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Degrees of flexion during positioning

研究概览

简要总结

Thoracotomy surgeries, both open and video assisted, are often carried out in the lateral decubitus position to optimize surgical access to the operative side. However, this position is also associated with mechanical injuries of the shoulder joint ligaments and pulling on the structures of the brachial plexus. The neck is laterally flexed and has potential to cause mechanical injury as well due to the dependent position of the patient's head.

The current method of positioning involves stacking of towels under a head support. To the study team's knowledge, no pre-formed head and neck support exists that can cope with the required surgical position. Thus, the study team has conceptualized an adaptive head and neck support pillow to meet this need and address patient safety concerns.

详细描述

Thoracotomy surgeries, both open and video assisted, are often carried out in the lateral decubitus position. This necessitates the flexion of the surgical table into an inversed 'v' shape to optimize surgical access to the operative side.

However, this position is also associated with mechanical injuries of the shoulder joint ligaments and pulling on the structures of the brachial plexus. With the dependent position of the patient's head, the neck is laterally flexed and has potential to cause mechanical injury as well. Normal cervical flexion range of motion is about 20-45 degrees, although this may be restricted in patients with cervical spine pathology or in the elderly. Ipsilateral shoulder pain (ISP) post thoracic surgery is a recognized complication and can be difficult to treat. While referred pain from the phrenic nerve is the well-studied cause, some literature noted that ipsilateral shoulder pain of the musculoskeletal type is more intense than referred ipsilateral shoulder pain. Rarer complications are not well reported but may include paraplegia and winging of the scapula. Positioning is also more challenging in obese patients, accompanied by a higher risk of position related complications.

The current method of positioning involves stacking of towels under a head support. To the study team's knowledge, no pre-formed head and neck support exists that can cope with the required surgical position, movements during the flexing and unflexing of the surgical table, as well as the different physical attributes of different patients.

The study team is concerned regarding the inherent dangers to patient safety, such as slippage or instability of a stack of towels, and the need for at least 3 personnel to help support the patient's head and neck adequately during positioning. With the anaesthetist preoccupied with holding the patient's head during positioning, there is the potential for inattention to other important issues such as haemodynamic changes. Existing methods of using a bean bag have fallen out of favor in our institution due to restriction of surgical access, bulkiness of the bean bag, need for a suction pump, and risk of pressure injury. The bean bag's main application is for maintaining the body in a lateral position, not for head and neck support.

Hence, the study team conceptualized the adaptive head and neck support pillow to meet this need and address patient safety concerns. Beyond thoracic surgery, it is hoped it will have applications in other situations requiring lateral decubitus positioning with flexion of the surgical table, such as nephrectomies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

One group of patients will receive the existing method of head support (control group), the other group will receive the prototype head and neck support device (study group)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 years and above
  • Listed for elective thoracic surgery in the lateral decubitus position

排除标准

  • Patient refusal
  • Age below 21 years
  • Emergency cases
  • Pregnant patients
  • Cognitively impaired patients
  • Unconscious patients

结局指标

主要结局

Degrees of flexion during positioning

时间窗: Intraoperatively

During positioning of patient, the goniometer will be used to measure and record the degree of lateral neck movement during the positioning process. Degrees of deviation from the maximum comfortable degree of the patient's lateral flexion calculated.

次要结局

  • User Satisfaction(Immediate postoperative)
  • Post-operative follow-up(Postoperative days 1 and 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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