GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

Last updated: June 16, 2024
Sponsor: Beijing Tongren Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Goal-Directed Fluid Therapy

Clinical Study ID

NCT06468852
TREC2024-KY059
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (Age≥18)

  • Scheduled to undergo head and neck cancer surgery (including nasopharyngealcarcinoma, laryngocarcinoma, hypopharyngeal carcinoma, and other head and neckmalignancies, but not thyroid cancer) with an expected duration of 2 hours or longer

  • Agree to receive invasive artery blood pressure monitoring

Exclusion

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification>Ⅳ

  • 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

  • NYHA grade>3 or ejection fraction <30%

  • Lung disease does not tolerate the tidal volume by 8 ml/kg

  • Atrial fibrillation

  • Unable to give informed consent

  • pregnant or lactating woman

  • Emergency surgery

Study Design

Total Participants: 340
Treatment Group(s): 1
Primary Treatment: Goal-Directed Fluid Therapy
Phase:
Study Start date:
May 16, 2024
Estimated Completion Date:
December 31, 2026

Study Description

Postoperative complications have become the main cause of prolonged hospitalization and reduced postoperative survival rate among surgical patients. Goal-Directed Fluid Therapy (GDFT) has been reported to reduce the incidence of postoperative complications and mortality, shorten the hospital stay, and improve the outcome in major abdominal surgery patients. However, the benefit of the GDFT in patients undergoing head and neck surgery remains controversial. The purpose of this study is to evaluate whether GDFT can reduce the occurrence of serious postoperative complications and shorten the postoperative hospital stay, compared with a standard conventional fluid therapy in patients undergoing head and neck cancer surgery.

Connect with a study center

  • Beijing tongren Hospital, Capital Medical University

    Beijing, Beijing 100730
    China

    Active - Recruiting

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