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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03176680
Other study ID # 201612093RINB
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 11, 2017
Last updated June 2, 2017
Start date June 15, 2017
Est. completion date March 2020

Study information

Verified date May 2017
Source National Taiwan University Hospital
Contact Ya-Jung Cheng, PhD
Phone +886-2-2312-3456
Email chengyj@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goals of this study are to testify the effectiveness on enhancement recovery by new anesthetic ERAS (Enhanced recovery after surgery) strategy.


Description:

ERAS (Enhanced recovery after surgery) strategy is extremely important for patients receiving esophagectomy including the preoperative preparation (smoking cessation, exercise prescription and nutrition prescription), intraoperative management, and postoperative analgesia and respiratory rehabilitation. However, despite the less invasive thoracoscopic esophagectomy and laparoscopic gastric tube reconstruction was developed, respiratory complications including acute lung injury (ALI) were observed up to 20% and associate with 50% of mortality. A new preventive anesthetic ERAS strategy including precise perioperative fluid management and preventive management after tracheal extubation should be developed.

Previous report indicated that none of the variables studied except fluid administration were shown as a risk factor for the development of respiratory complications on the multivariate analysis on esophageal surgery. However, there are rare prospective investigations of perioperative fluid administration strategy on postoperative complications after esophagectomy. Our group has studied on goal-directed fluid optimization and we found that the goal of optimization may differ for specific surgery. For esophagectomy, new anesthetic ERAS strategy should include precise preoptimized circulatory management and aggressive postoperative pulmonary care. Based on Frank-Starling law (stroke volume, SV, response to fluid therapy), a precise goal for perioperative goal-directed fluid therapy (GDFT) becomes possible in anesthetic practice. However, the effects of preoperative maximization of SV remain unknown. Following our study in last year, we planned to randomize 120 esophagectomy patients in the following 3 years into different GDFT groups (SV maximization and SV normalization groups). Postoperative THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) therapy will be take place immediately after tracheal extubation. Blood samples will be obtained preoperatively to postoperative day 1 to measure lung injuries, kidney injuries as well as the inflammatory and oxidative markers. The clinical records will be collected (including extubation time, ICU stay, hospitalization days, 30-day mortality, 90-day mortality, readmission, postoperative cardiovascular, pulmonary, and renal complications, gastric tube related complications etc. ). The goals of this study are to testify the effectiveness on enhance recovery by new anesthetic ERAS strategy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date March 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 35 Years to 65 Years
Eligibility Inclusion criteria:

- Patients with esophageal cancer

- Patients will undergo video-assisted thoracic surgical (VATS) esophagectomy and laparoscopic gastric tube reconstruction

Exclusion criteria:

- History of arrhythmia

- History of chronic obstructive pulmonary disease (COPD)

- With poor lung function test (FEV1 < 70% or FEV1/ forced vital capacity (FVC) < 70% of predicted)

- Preoperative creatinine more than 1.5 mg/dl

Study Design


Intervention

Procedure:
Fluid therapy optimization
colloid 250 mL bolus to increase stroke volume index (SVI). If the increase of SVI is more than 10% of baseline, repeat the bolus. If the increase of SVI is less than 10% of baseline, stop the bolus.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei Test2

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications Length of ICU stay, total hospitalization days, 30-day mortality, 90-day mortality, postoperative pulmonary complications, cardiovascular complications, renal complications, prolonged extubation, readmission, gastric tube related complications within 1 year after operation
Secondary Kidney injuries Elevated plasma creatinine Preoperative to postoperative day 1
Secondary Lung injuries Change in the (PF ratio): ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2) Preoperative to postoperative day 1
Secondary Inflammatory markers Change in cytokines Preoperative to postoperative day 1
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