Chest-Up: Obtaining Safe Positioning for Thoracic Surgery

NCT04462497 | Unknown

• 1 other identifier: 2019/00637
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic

Keywords

Intraoperative; Lateral decubitus

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraoperatively

Secondary Outcomes (2)

• Post-operative follow-up

  Postoperative days 1 and 2

• User Satisfaction

  Immediate postoperative

Study Arms (2)

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.

Other: Prototype device

Interventions

Prototype device OTHER

Patients will receive the prototype head and neck support device to be used intraoperatively.

Study Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (4)

• 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.

  PMID: 27576216 BACKGROUND

• Yousefshahi 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.

  PMID: 28018130 BACKGROUND

• Bhuiyan 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.

  PMID: 9709146 BACKGROUND

• Martin JT. Postoperative isolated dysfunction of the long thoracic nerve: a rare entity of uncertain etiology. Anesth Analg. 1989 Nov;69(5):614-9.

  PMID: 2552867 BACKGROUND

Study Officials

• Xian Li Deborah Khoo

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xian Li Deborah Khoo

CONTACT

97585794; deborah_khoo@nuhs.edu.sg

Theng Wai Foong

CONTACT

96209087; theng_wai_foong@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: July 23, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)