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NCT Number: NCT06468852

GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

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.

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Key information

Conditions

Postoperative Complications Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Guyan Wang

CONTACT

[email protected]

+8613910985139

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Goal-Directed Fluid Therapy

Procedure

Stroke volume variation (SVV)≤12% and cardiac index (CI)≥2.5L/min/m2 are the goals of Goal-Directed fluid therapy, while the mean arterial pressure (MAP) are kept between 65 and 90 mmHg. 5mL/kg of crystalloids will be infused during induction period, followed by an infusion rate of 2 mL/kg/h to supplement the physiological requirements. If SVV>12% for more than 5 min, a 250 mL bolus of colloid is given. Another 250 ml bolus of colloid is administrated if SVV was still more than 12% or SV decreased over 10%. If the CI<2.5 L/min/m2, inotropes are used to achieve this minimum CI, serving as a safety parameter to prevent the patient from being exposure to a low cardiac output state. If SVV and CI reached the s target range but MAP could not maintain the expected level, vasopressors were started. Assess the patients every 5min intraoperatively to ensure that all parameters adhere to the target range according to the study algorithm.

Primary outcomes

  1. Serious complications occurred within 30 days after surgery

    Time frame: within 30 days after surgery

    Unit: %; All postoperative complications will be evaluated according the Clavien-Dino classification(CDc) of surgical complications. Each complication has an equal weight, and patients with at least one complication will be considered to have experienced postoperative complications.

    The serious postoperative complications were defined as CDc≥3.

Secondary outcomes

  1. All complications within 30 days after surgery

    Time frame: within 30 days after surgery

    Unit: %;All postoperative complications will be evaluated according the Clavien-Dino classification(CDc) of surgical complications.

  2. The length of hospital stay after surgery

    Time frame: 1 months after operation

    Unit: days; from date of operation till date of discharge

  3. Cost of hospitalization

    Time frame: 1 months after operation

    Unit: yuan; Total cost during hospitalization

  4. Quality of Recovery Score

    Time frame: At 1,3, and 5 days after surgery

    Unit: point; Use QoR-15 to evaluate the postoperative recovery of all patients. QoR-15 is a global measure of recovery after surgery that evaluates five dimensions of recovery: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11- point scale based on its frequency on the questionnaire (greater score at greater frequency for positive items and less frequency for negative items). The total score ranged from 0 (poorest recovery quality) to 150 (best recovery quality).

Study contacts

Contact information is provided by the study sponsor or research team.

Xuan Liang, master

CONTACT

[email protected]

+8613810261846

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

Effect of Goal-Directed Fluid Therapy on the Postoperative Outcome in Head and Neck Cancer Surgery: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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