Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04462497
Study type Interventional
Source National University Hospital, Singapore
Contact Xian Li Deborah Khoo
Phone 97585794
Email deborah_khoo@nuhs.edu.sg
Status Recruiting
Phase N/A
Start date July 23, 2020
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT06049264 - Thoracic Spine Manual Traction With Mobilization Versus Manipulation N/A
Completed NCT04251637 - Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery
Withdrawn NCT05100160 - Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial) Phase 3
Not yet recruiting NCT04546594 - Epidemiological Data on Pain
Terminated NCT03962036 - Effect of One-lung Ventilation on BIS Values
Completed NCT05091398 - Erector Spinae Plane, Paravertebral Versus Intercostal Nerve Block for VATS Surgery N/A
Completed NCT05091281 - Macintosh Versus GlideScope Versus C-MAC for Double Lumen Endotracheal Intubation N/A
Completed NCT01476761 - MicroCutter in Surgical Stapling - European Trial I Phase 4
Active, not recruiting NCT06252740 - Investigation of Regional Interdependence of the Hip and Spine in Baseball Players With Low Back Pain
Recruiting NCT06075316 - Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS) N/A
Completed NCT05392517 - Effects of Self-mobilization Techniques in Chronic Thoracic Pain N/A
Completed NCT05395078 - Effects of Thoracic Extension Versus Thoracic Stabilization Exercises in Patients With Maigne's Thoracic Pain N/A
Active, not recruiting NCT05798585 - Comparing Erector Spinae Plane (ESP) and Thoracic Paravertebral (TPV) Block Analgesic Effect After Elective VATS N/A
Not yet recruiting NCT06253741 - Rhomboid Intercostal and Subserratus / Paravertebral Block N/A
Completed NCT05204537 - The Role of Surgery in Patients With Coronavirus Disease - 19 (COVID-19) Related Thoracic Complications
Completed NCT04246099 - Opioid-free Anesthesia in Thoracic Surgery
Not yet recruiting NCT06434727 - Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures.
Terminated NCT02259452 - Radiation Induced Cardiopulmonary Injury in Humans
Completed NCT03708198 - Pharmacokinetics of Single-Dose Liposomal Bupivacaine in Surgeon Performed Intercostal Nerve Blocks Phase 4
Completed NCT04964973 - Effect of Transcutaneous Electro-stimulation in Ambulatory Postoperative Rehabilitation Treatment in Thoracic Surgery. N/A