Ignite Creation Date:
2024-05-06 @ 2:55 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04462497
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2020-07-02
Brief Title:
Chest-Up Obtaining Safe Positioning for Thoracic Surgery
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Chest-Up Obtaining Safe Positioning for Thoracic Surgery
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients head
The current method of positioning involves stacking of towels under a head support To the study teams 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
The current method of positioning involves stacking of towels under a head support To the study teams 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 patients 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 teams 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 patients head and neck adequately during positioning With the anaesthetist preoccupied with holding the patients 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 bags 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
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 patients 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 teams 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 patients head and neck adequately during positioning With the anaesthetist preoccupied with holding the patients 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 bags 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None