ThoracicNCT04462497
Chest-Up: Obtaining Safe Positioning for Thoracic Surgery
A study testing Prototype device in people with Thoracic, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Thoracic
- What is being tested?
- Prototype device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Jul 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years and above
- Listed for elective thoracic surgery in the lateral decubitus position
Who cannot join
- Patient refusal
- Age below 21 years
- Emergency cases
- Pregnant patients
- Cognitively impaired patients
- Unconscious patients
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Xian Li Deborah Khoo, 97585794, deborah_khoo@nuhs.edu.sg
Dr Xian Li Deborah Khoo
About this study
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.
Read the 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.
- Conditions
- Thoracic
- Being tested
- Prototype device
- Keywords
- Intraoperative, Lateral decubitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype deviceOther
Patients will receive the prototype head and neck support device to be used intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants will receive the existing method of head support (sponge and towel stack) intraoperatively. |
| Study Group | Experimental | Participants will receive the prototype head and neck support device intraoperatively. Receives: Other: Prototype device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degrees of flexion during positioning
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.
Measured: Intraoperatively
Secondary outcomes (2)
Post-operative follow-up
Patient will be contacted on postoperative day 1 and 2 to ask about neck or shoulder pain, numbness or weakness.
Measured: Postoperative days 1 and 2
User Satisfaction
Gather user satisfaction feedback from surgeons and anaesthetists regarding usability and satisfaction using a Likert scale.
Measured: Immediate postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start23 Jul 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ThoracicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be 2 groups of a patients randomized to either the existing method of head support (sponge and towel stack) or prototype head and neck support device.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Xian Li Deborah Khoo, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462497
- Sponsor's protocol ID
- 2019/00637
- Other IDs
- 2019
- Status last verified
- Jun 2023
- First submitted
- 2 Jul 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blichfeldt-Eckhardt MR, Andersen C, Ording H, Licht PB, Toft P. Shoulder Pain After Thoracic Surgery: Type and Time Course, a Prospective Cohort Study. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):147-151. doi: 10.1053/j.jvca.2016.04.032. Epub 2016 May 9.
PubMed 27576216Yousefshahi F, Predescu O, Colizza M, Asenjo JF. Postthoracotomy Ipsilateral Shoulder Pain: A Literature Review on Characteristics and Treatment. Pain Res Manag. 2016;2016:3652726. doi: 10.1155/2016/3652726. Epub 2016 Nov 28.
PubMed 28018130Bhuiyan MS, Mallick A, Parsloe M. Post-thoracotomy paraplegia coincident with epidural anaesthesia. Anaesthesia. 1998 Jun;53(6):583-6. doi: 10.1046/j.1365-2044.1998.00470.x.
PubMed 9709146Martin JT. Postoperative isolated dysfunction of the long thoracic nerve: a rare entity of uncertain etiology. Anesth Analg. 1989 Nov;69(5):614-9.
PubMed 2552867
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest-Up: Obtaining Safe Positioning for Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04462497
- Acronym / sponsor ID
- 2019/00637
- Conditions
- Thoracic
- Keywords
- Intraoperative, Lateral decubitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There will be 2 groups of a patients randomized to either the existing method of head support (sponge and towel stack) or prototype head and neck support device.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants will receive the existing method of head support (sponge and towel stack) intraoperatively. |
| Study Group | Experimental | Other: Prototype deviceParticipants will receive the prototype head and neck support device intraoperatively. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 21 years and above
- Listed for elective thoracic surgery in the lateral decubitus position
Key exclusion criteria (6 listed)
- Patient refusal
- Age below 21 years
- Emergency cases
- Pregnant patients
- Cognitively impaired patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype devicePatients will receive the prototype head and neck support device to be used intraoperatively. | Other | Study Group |
Primary outcome
Degrees of flexion during positioning
Time frame: 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.
2 secondary outcomes
Post-operative follow-up
Time frame: Postoperative days 1 and 2
User Satisfaction
Time frame: Immediate postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 27576216Blichfeldt-Eckhardt MR, Andersen C, Ording H, Licht PB, Toft P. Shoulder Pain After Thoracic Surgery: Type and Time Course, a Prospective Cohort Study. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):147-151. doi: 10.1053/j.jvca.2016.04.032. Epub 2016 May 9.
- Background: PubMed 28018130Yousefshahi F, Predescu O, Colizza M, Asenjo JF. Postthoracotomy Ipsilateral Shoulder Pain: A Literature Review on Characteristics and Treatment. Pain Res Manag. 2016;2016:3652726. doi: 10.1155/2016/3652726. Epub 2016 Nov 28.
- Background: PubMed 9709146Bhuiyan MS, Mallick A, Parsloe M. Post-thoracotomy paraplegia coincident with epidural anaesthesia. Anaesthesia. 1998 Jun;53(6):583-6. doi: 10.1046/j.1365-2044.1998.00470.x.
- Background: PubMed 2552867Martin JT. Postoperative isolated dysfunction of the long thoracic nerve: a rare entity of uncertain etiology. Anesth Analg. 1989 Nov;69(5):614-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xian Li Deborah Khoo principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype device in people with Thoracic, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xian Li Deborah Khoo (97585794, deborah_khoo@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degrees of flexion during positioning (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462497, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.