Clinical trial NCT06974552: The Effect of Different Support Surface Applications
Official title: The Effect of Different Support Surface Applications on Pressure Injury and Pain in Patients Undergoing Robotic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pressure Incidence Prevention
Pain
Keywords: pressure injury
robotic surgery
deep trendelenburg position
pain
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed as a randomized controlled experimental study to compare the effects of two support surfaces-gel pads (used in routine practice) and microbead-filled pads-placed under the shoulders in the steep Trendelenburg position during robotic surgery, on the development of pressure injuries and pain.

Detailed description: Safe and procedure-specific patient positioning is a critical component of successful surgical outcomes. In robotic surgeries, particularly those involving the lower pelvic region, the steep Trendelenburg position is frequently used to optimize surgical exposure. However, as the angle of the Trendelenburg position increases and the patient remains in this posture for a prolonged period, the risk of adverse events such as nerve injuries, pressure injuries, and deep tissue ischemia also increases.

Unlike traditional surgeries where repositioning the patient may be possible during the procedure, robotic surgeries do not allow for intraoperative repositioning due to the fixed docking of robotic arms. Consequently, safe and effective positioning strategies are essential to prevent patient movement and minimize the risk of skin and soft tissue damage.

The current systems used for managing patients in the steep Trendelenburg position are suboptimal. There is limited evidence in the literature regarding the incidence and prevention of pressure injuries associated with this specific position during robotic surgery. Prolonged immobility in this posture increases friction and pressure at contact surfaces, which can lead to pressure-related injuries.

The use of appropriate support surfaces is therefore vital to reduce the risk of such injuries. This study aims to address this gap by evaluating and comparing different support surfaces placed under the shoulders during robotic surgery in the steep Trendelenburg position, with a focus on their effects on pressure injury development and postoperative pain.

Hypotheses of the study H1: The use of microbead-filled support surfaces under the shoulders is superior to gel support surfaces in preventing pressure injuries and pain.

H2: The use of gel support surfaces under the shoulders is superior to microbead-filled support surfaces in preventing pressure injuries and pain.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo robotic surgery in the lower pelvic region in the steep Trendelenburg position
* Patients aged 18 years and older

Exclusion Criteria:

* Patients with existing pressure injuries
* Patients with communication barriers
* Patients with skin anomalies that interfere with skin assessment
* Patients requiring conversion to open surgery during the procedure
* Patients whose position is changed during surgery

Primary outcomes:
measure: Change in the pressure injury condition
timeFrame: At the time of admission to the operating room, immediately after surgery, one hour after surgery, 12 hour after surgery, 24 hour after surgery. The change in this time intervals will be assessed.
measure: Change in the pain level
timeFrame: Pain will be assessed every 15 minutes during the first two hours after surgery, and then every 30 minutes for the following one hour.The change in this time intervals will be assessed.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University
state: Ataşehir
Study officials:
References:
citation: Safe Practices When Positioning Patients in the Trendelenburg Position. AORN J. 2024 May;119(5):P9. doi: 10.1002/aorn.14134. No abstract available.
citation: Celik B, Karayurt O, Ogce F. The Effect of Selected Risk Factors on Perioperative Pressure Injury Development. AORN J. 2019 Jul;110(1):29-38. doi: 10.1002/aorn.12725.
citation: Engels D, Austin M, McNichol L, Fencl J, Gupta S, Kazi H. Pressure Ulcers: Factors Contributing to Their Development in the OR. AORN J. 2016 Mar;103(3):271-81. doi: 10.1016/j.aorn.2016.01.008.
citation: Chen Y, Wang W, Qian Q, Wu B. Comparison of four risk assessment scales in predicting the risk of intraoperative acquired pressure injury in adult surgical patients: a prospective study. J Int Med Res. 2023 Oct;51(10):3000605231207530. doi: 10.1177/03000605231207530.