Chest-Up: Obtaining Safe Positioning for Thoracic Surgery

Not Applicable

Recruiting

• Conditions: Thoracic
• Interventions: Other: Prototype device

• Registration Number: NCT04462497
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-08
• Study Start: 2020-07-23
• Status Verified: 2023-06
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Prototype device	Participants will receive the prototype head and neck support device intraoperatively.

Primary Outcome Measures

Name	Time	Method
Degrees of flexion during positioning	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.

Secondary Outcome Measures

Name	Time	Method
User Satisfaction	Immediate postoperative	Gather user satisfaction feedback from surgeons and anaesthetists regarding usability and satisfaction using a Likert scale.
Post-operative follow-up	Postoperative days 1 and 2	Patient will be contacted on postoperative day 1 and 2 to ask about neck or shoulder pain, numbness or weakness.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore