Ataturk University has announced a new randomized controlled trial examining the effects of intraoperative warming methods on hematologic inflammatory indices during laparoscopic cholecystectomy procedures. This study, which is set to begin recruiting patients, will evaluate the performance and clinical safety of three distinct warming devices aimed at reducing perioperative hypothermia and minimizing inflammatory responses associated with surgical stress.
The trial’s findings are expected to inform healthcare professionals, regulatory teams, and surgical device designers about best practices in temperature management during surgical procedures. The insights will also aid compliance with medical device performance and safety standards.
In this article:
- What are the study’s clinical objectives?
- How do the warming devices differ?
- What outcomes could shape medical device practices?
- Frequently Asked Questions
- Key takeaways and next steps
- Disclaimer
- Official trial announcement
What are the study’s clinical objectives?
The trial focuses on evaluating intraoperative warming techniques aimed at reducing perioperative hypothermia, a common condition during surgeries involving general anesthesia. Perioperative hypothermia has been linked to prolonged recovery times, increased surgical site infections, and heightened inflammatory responses. By studying three different warming interventions—standard active warming blankets, intravenous warming technologies, and external warming devices—researchers aim to identify effective methods to optimize surgical temperature management.
The study will analyze how each intervention impacts hematologic inflammatory indices, which are key indicators of the body’s response to surgical stress. This data will provide the groundwork necessary for enhancing patient safety and validating medical device performance.
How do the warming devices differ?
The study includes three device-based interventions. Each represents a distinct approach to intraoperative warming:
- Standard Active Warming Blanket: A widely used device that provides external thermal regulation during surgical procedures.
- Intravenous Warmer Group: Devices that maintain the temperature of fluids and medications administered intravenously to reduce core temperature fluctuations.
- External Warmer Group: Advanced systems delivering targeted, localized warming to specific areas of the patient’s body.
By comparing these devices, the trial aims to identify which method offers the best combination of efficacy and safety in terms of reducing hypothermia and mitigating inflammatory responses.
What outcomes could shape medical device practices?
The trial is expected to yield results that could influence regulatory standards, surgical protocols, and device innovation. Key anticipated findings include:
- Performance metrics for each warming device in managing core body temperature.
- Insights into the impact of warming methods on hematologic inflammatory indices and the broader surgical stress response.
- Evidence to inform regulatory submissions and compliance strategies for manufacturers of surgical warming devices.
The data could pave the way for improvements in intraoperative temperature management protocols, aligning patient safety goals with device effectiveness.
Frequently Asked Questions
- Is the trial currently recruiting?
Not yet. The trial is listed as “not yet recruiting” on ClinicalTrials.gov. - What conditions will be addressed?
The trial targets perioperative hypothermia and examines its link to inflammatory responses during laparoscopic cholecystectomy. - Who is sponsoring the study?
The study is sponsored by Ataturk University. - How can I learn more?
Visit the trial’s official ClinicalTrials.gov listing using the link at the bottom of this article.
Key takeaways and next steps
This upcoming trial seeks to redefine intraoperative temperature management practices by delivering evidence-based comparisons of warming device performance and safety. With a focus on minimizing perioperative complications and improving patient care, the study could inform future medical device designs, regulatory compliance measures, and surgical protocols.
Stakeholders in medical devices, healthcare, and regulatory affairs should monitor this study closely for actionable insights.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or medical advice. Stakeholders are advised to consult relevant regulatory authorities or legal professionals for guidance tailored to their circumstances.
Official trial announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07232251?term=medical+device