Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection

Goal-directed Fluid Therapy Clinical Trial

Official title:

Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237351
• Other study ID #: 2017041102
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Shenzhen Second People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Goal-directed Fluid Therapy

Intervention

Device:
• Fluid therapy
Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
ZhiHeng Liu

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation

Ripollés-Melchor J, Espinosa Á, Martínez-Hurtado E, Abad-Gurumeta A, Casans-Francés R, Fernández-Pérez C, López-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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Oxygenation Index in 48 hours		Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation
Secondary	The duration of surgery		During surgery period
Secondary	The duration of mechanical ventilation		During surgery period
Secondary	Crystalloid administered		During surgery period
Secondary	Colloid administered		During surgery period
Secondary	Blood loss		During surgery period
Secondary	Urine output		During surgery period
Secondary	Number of patients received vasopressor		During surgery period
Secondary	Blood pressure		Before the surgery and 48 hours after surgery
Secondary	Leukocyte		Before the surgery and 48 hours after surgery
Secondary	Hematocrit		Before the surgery and 48 hours after surgery
Secondary	Complication until hospital discharge		1 month after surgery
Secondary	Hospital stay postoperatively		1 month after surgery