Goal Directed Fluid Management Based on Non-invasive Monitoring

Postoperative Complication Clinical Trial

Official title:

Goal-Directed Fluid Management Based on Non- Invasive Monitoring of Pulse Oximeter-Derived Pleth Variability Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883752
• Other study ID #: UCIANES01
• Status: Completed
• Phase: N/A
• First received: March 7, 2012
• Last updated: February 9, 2016
• Start date: July 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2016
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether goal directed fluid management using respiratory variations in the oxygen saturation by pulse oximetry (SpO2) waveform has potential to decrease postoperative complications and outcomes.

Description:

The aim of this study is to test the hypothesis that monitoring and minimizing the respiratory variations in the pulse oximeter waveform amplitude by volume loading has potential to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery.

In this study the investigators will test the impact of hemodynamic optimization based on the respiratory variations in the plethysmographic waveform amplitude to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery. The primary outcome variable is the incidence of postoperative complications. Secondary outcome variables are the duration of hospital and ICU stays, postoperative mortality, and cost of surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients (male or female)

• Over 18 years old undergoing non-cardiac surgery

• Weight > 40 kg, Body Mass Index < 40

Exclusion Criteria:

• Patients who do not consent

• Body Mass Index > 40

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Complication
• Postoperative Complications

Intervention

Procedure:
• Goal-directed Therapy group
Fluid administration is based on the respiratory variation in the pulse oximeter waveform

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (10)

Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. — View Citation

Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational approach to perioperative fluid management. Anesthesiology. 2008 Oct;109(4):723-40. doi: 10.1097/ALN.0b013e3181863117. Review. — View Citation

Conway DH, Mayall R, Abdul-Latif MS, Gilligan S, Tackaberry C. Randomised controlled trial investigating the influence of intravenous fluid titration using oesophageal Doppler monitoring during bowel surgery. Anaesthesia. 2002 Sep;57(9):845-9. — View Citation

Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. — View Citation

Lebuffe G, Vallet B, Takala J, Hartstein G, Lamy M, Mythen M, Bakker J, Bennett D, Boyd O, Webb A. A european, multicenter, observational study to assess the value of gastric-to-end tidal PCO2 difference in predicting postoperative complications. Anesth Analg. 2004 Jul;99(1):166-72. — View Citation

Mythen MG, Webb AR. Intra-operative gut mucosal hypoperfusion is associated with increased post-operative complications and cost. Intensive Care Med. 1994;20(2):99-104. — View Citation

Poeze M, Greve JW, Ramsay G. Meta-analysis of hemodynamic optimization: relationship to methodological quality. Crit Care. 2005;9(6):R771-9. Epub 2005 Nov 15. Review. — View Citation

Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. — View Citation

Venn R, Steele A, Richardson P, Poloniecki J, Grounds M, Newman P. Randomized controlled trial to investigate influence of the fluid challenge on duration of hospital stay and perioperative morbidity in patients with hip fractures. Br J Anaesth. 2002 Jan;88(1):65-71. — View Citation

Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. Epub 2005 Sep 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospital stay	The length of stay in the hospital is defined as postoperative number of days in the hospital until discharge.	Maximum 90 days after surgery	Yes