Clinical trial NCT06468852: GDFT on the Postoperative Outcome in Head and Neck Cancer Surgery
Official title: Effect of Goal-Directed Fluid Therapy on the Postoperative Outcome in Head and Neck Cancer Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Complications
Keywords: Postoperative Complications
Early Goal-Directed Therapy
Fluid therapy
Head and Neck Neoplasms
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Serious complications occurred within 30 days after surgery
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: All complications within 30 days after surgery
timeFrame: within 30 days after surgery
measure: The length of hospital stay after surgery
timeFrame: 1 months after operation
measure: Cost of hospitalization
timeFrame: 1 months after operation
measure: Quality of Recovery Score
timeFrame: At 1,3, and 5 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing tongren Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital, CMU
name: Guyan Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.