NCT06468852Recruiting
GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery
Effect of Goal-Directed Fluid Therapy on the Postoperative Outcome in Head and Neck Cancer Surgery: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 21 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate whether goal-directed fluid therapy (GDFT) can improve the postoperative recovery in patients undergoing head and neck cancer surgery. It aims to answer is: • Whether GDFT can reduce the occurrence of serious postoperative complications? Researchers will compare GDFT protocol to a standard conventional fluid therapy in head and neck cancer surgery to see if GDFT strategy works to improve the postoperative recovery. Participants will * Receive GDFT protocol or a conventional fluid therapy during the surgery. * Be continuously follow-up during hospitalization and after discharge to record the occurrence of postoperative complications.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 4 Jun 2024
- Start date
- 16 May 2024
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Beijing Tongren Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT06468852
What you commit to
- Study type: Interventional
- Planned participants: 340
- From 16 May 2024 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Palliative surgery was performed for the terminal tumors
- Microlaryngoscopic laser surgery or endoscopic surgery
- Underwent major thoracic or abdominal surgery within 30 days
- Regular renal replacement therapy is required
- Emergency surgery
Other illness
- Lung disease does not tolerate the tidal volume by 8 ml/kg
Lab values
- NYHA grade\>3 or ejection fraction \<30%
Other
- American Society of Anesthesiologists (ASA) classification\>Ⅳ
- Atrial fibrillation
- Unable to give informed consent
- pregnant or lactating woman
Who the study is looking for
- Adult patients (Age≥18)
- Scheduled to undergo head and neck cancer surgery (including nasopharyngeal carcinoma, laryngocarcinoma, hypopharyngeal carcinoma, and other head and neck malignancies, but not thyroid cancer) with an expected duration of 2 hours or longer
- Agree to receive invasive artery blood pressure monitoring
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.