GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery

NCT06468852 | Recruiting

• 1 other identifier: TREC2024-KY059
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complications

Keywords

Postoperative Complications; Early Goal-Directed Therapy; Fluid therapy; Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Serious complications occurred 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.

  within 30 days after surgery

Secondary Outcomes (4)

• All complications within 30 days after surgery

  within 30 days after surgery

• The length of hospital stay after surgery

  1 months after operation

• Cost of hospitalization

  1 months after operation

• Quality of Recovery Score

  At 1,3, and 5 days after surgery

Study Arms (2)

GDFT group

EXPERIMENTAL

Patients in GDFT group will receive GDFT protocol, Stroke volume variation (SVV)≤12% and cardiac index (CI)≥2.5L/min/m2 are the goals of 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.

Procedure: Goal-Directed Fluid Therapy

conventional fluid therapy group

NO INTERVENTION

Patients in conventional fluid therapy group, fluid management will be carried out according to the clinical practice routine, maintaining MAP≥65mmHg and urine output ≥0.5ml/kg/h, intraoperatively. When the anesthesiologist empirically determines that the fluid infusion is sufficient but MAP does not maintain the expected level, vasopressor or inotropic drugs are given to maintain the blood pressure.

Interventions

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.

GDFT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (8)

• Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

  PMID: 22998715 BACKGROUND

• McMahon JD, MacIver C, Smith M, Stathopoulos P, Wales C, McNulty R, Handley TP, Devine JC. Postoperative complications after major head and neck surgery with free flap repair--prevalence, patterns, and determinants: a prospective cohort study. Br J Oral Maxillofac Surg. 2013 Dec;51(8):689-95. doi: 10.1016/j.bjoms.2013.04.015. Epub 2013 May 31.

  PMID: 23727043 BACKGROUND

• Loeffelbein DJ, Julinek A, Wolff KD, Kochs E, Haller B, Haseneder R. Perioperative risk factors for postoperative pulmonary complications after major oral and maxillofacial surgery with microvascular reconstruction: A retrospective analysis of 648 cases. J Craniomaxillofac Surg. 2016 Aug;44(8):952-7. doi: 10.1016/j.jcms.2016.05.007. Epub 2016 May 14.

  PMID: 27259678 BACKGROUND

• Liang X, Chen X, Wang G, Wang Y, Shi D, Zhao M, Zheng H, Cui X. Intraoperative hypotension, oliguria and operation time are associated with pulmonary embolism after radical resection of head and neck cancers: a case control study. BMC Anesthesiol. 2021 Dec 3;21(1):304. doi: 10.1186/s12871-021-01521-4.

  PMID: 34856931 BACKGROUND

• Dushianthan A, Knight M, Russell P, Grocott MP. Goal-directed haemodynamic therapy (GDHT) in surgical patients: systematic review and meta-analysis of the impact of GDHT on post-operative pulmonary complications. Perioper Med (Lond). 2020 Oct 15;9:30. doi: 10.1186/s13741-020-00161-5. eCollection 2020.

  PMID: 33072306 BACKGROUND

• Sun Y, Chai F, Pan C, Romeiser JL, Gan TJ. Effect of perioperative goal-directed hemodynamic therapy on postoperative recovery following major abdominal surgery-a systematic review and meta-analysis of randomized controlled trials. Crit Care. 2017 Jun 12;21(1):141. doi: 10.1186/s13054-017-1728-8.

  PMID: 28602158 BACKGROUND

• Reiterer C, Kabon B, Zotti O, Obradovic M, Kurz A, Fleischmann E. Effect of goal-directed crystalloid- versus colloid-based fluid strategy on tissue oxygen tension: a randomised controlled trial. Br J Anaesth. 2019 Dec;123(6):768-776. doi: 10.1016/j.bja.2019.08.027. Epub 2019 Oct 15.

  PMID: 31627889 BACKGROUND

• Liang X, Xi C, Zhou H, Wang S, Shi D, Wang Y, Shen W, Wang G. Effect of goal-directed fluid therapy on the postoperative outcome in head and neck cancer surgery: study protocol for a randomized controlled trial. Trials. 2025 Oct 15;26(1):412. doi: 10.1186/s13063-025-09152-7.

  PMID: 41094585 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Study Officials

• Guyan Wang

  Beijing Tongren Hospital, CMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuan Liang, master

CONTACT

+8613810261846; doctor_xuan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients were unaware of their group allocation. Due to the presence of the cardiac index trend monitoring device, care providers who supported to fluid strategy administration in the operating room could not be blinded. The outcomes assessor were blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 21, 2024
• Study Start: May 16, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)