Clinical trial NCT03237351: Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection
Official title: Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Goal-directed Fluid Therapy
Keywords: goal-directed fluid therapy
thoracic surgery, video-assisted
acute lung injury
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perioperative fluid management is a key component of anesthetic management during thoracic surgery. On one hand, fluid restriction could compromise perfusion of vital organs and surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary complications, notably pulmonary edema, which carries a high mortality rate. Perioperative fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed. Therefore, to achieve the balance between preventing fluid overload and optimising organ perfusion, the practical index to guide fluid management, which can predict whether fluid loading will improve haemodynamic conditions in an individual patient, would be very valuable during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory variations of arterial pressure \[i.e. pulse pressure variation (PPV) and systolic pressure variation\] can predict fluid responsiveness in mechanically ventilated patients under various conditions. Therefore, pressure variations are increasingly being advocated for fluid management.This study will discuss the effects of pulse pressure variation(PPV) in different level during anesthesia on patients with oxygenation index and short-term prognosis undergoing video-assisted thoracoscopic surgery for pneumoresection.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I-III; aged 18-60 years old; BMI 18.5 \~ 28 kg/m2

Exclusion Criteria:

* Refused to participate in the experiment, hepatic/renal/cardiac dysfunction, severe valvular disease, frequent arrhythmia, moderate anemia and severe electrolyte disturbance before operation.

Primary outcomes:
measure: Change from Baseline Oxygenation Index in 48 hours
timeFrame: Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation
Secondary outcomes:
measure: The duration of surgery
timeFrame: During surgery period
measure: The duration of mechanical ventilation
timeFrame: During surgery period
measure: Crystalloid administered
timeFrame: During surgery period
measure: Colloid administered
timeFrame: During surgery period
measure: Blood loss
timeFrame: During surgery period
measure: Urine output
timeFrame: During surgery period
measure: Number of patients received vasopressor
timeFrame: During surgery period
measure: Blood pressure
timeFrame: Before the surgery and 48 hours after surgery
measure: Leukocyte
timeFrame: Before the surgery and 48 hours after surgery
measure: Hematocrit
timeFrame: Before the surgery and 48 hours after surgery
measure: Complication until hospital discharge
timeFrame: 1 month after surgery
measure: Hospital stay postoperatively
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
References:
citation: Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
citation: Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
citation: Ripolles-Melchor J, Espinosa A, Martinez-Hurtado E, Abad-Gurumeta A, Casans-Frances R, Fernandez-Perez C, Lopez-Timoneda F, Calvo-Vecino JM. Perioperative goal-directed hemodynamic therapy in noncardiac surgery: a systematic review and meta-analysis. J Clin Anesth. 2016 Feb;28:105-15. doi: 10.1016/j.jclinane.2015.08.004. Epub 2015 Oct 2.
citation: Chau EH, Slinger P. Perioperative fluid management for pulmonary resection surgery and esophagectomy. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):36-44. doi: 10.1177/1089253213491014. Epub 2013 May 29.
citation: Zhang J, Chen CQ, Lei XZ, Feng ZY, Zhu SM. Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thoracoscopy lobectomy operations: a pilot study. Clinics (Sao Paulo). 2013 Jul;68(7):1065-70. doi: 10.6061/clinics/2013(07)27.
citation: Lee JH, Jeon Y, Bahk JH, Gil NS, Hong DM, Kim JH, Kim HJ. Pulse pressure variation as a predictor of fluid responsiveness during one-lung ventilation for lung surgery using thoracotomy: randomised controlled study. Eur J Anaesthesiol. 2011 Jan;28(1):39-44. doi: 10.1097/EJA.0b013e32834089cf.