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Clinical Trials/NCT02071524
NCT02071524
Unknown
Not Applicable

Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics

Università degli Studi di Ferrara1 site in 1 country40 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Cristalloid administration
Conditions
Mechanical Ventilation Complication
Sponsor
Università degli Studi di Ferrara
Enrollment
40
Locations
1
Primary Endpoint
effects on oxygenation, respiratory mechanics
Last Updated
9 years ago

Overview

Brief Summary

The investigators hypothesize that large doses of fluids used during intraoperative could affect lung parenchyma structure and, consequently, gas exchange and respiratory mechanics. The purpose of this study is to evaluate fluids effects on oxygenation, respiratory mechanics, by using two different solutions: crystalloid or colloid.

Detailed Description

Inclusion Criteria: * patients undergoing elective abdominal, thoracic, vascular surgery * minimum age 18 years * informed consent Exclusion Criteria: * patients with severe cardiomyopathy or severe heart failure * history of coagulation disorders * patients with severe cardiovascular or respiratory disorders * renal insufficiency Respiratory mechanic parameters (i.e., inspiratory peak pressure, plateau pressure, total airway resistance, and static compliance) are obtained .Blood samples are drawn simultaneously from the arterial catheters for gas analysis. Data were collected after induction of anesthesia (T0) after 1 h (T1), 2 h (T2), 3 h (T3) and at the end of surgery. Primary outcome: evaluate the fluids effects on oxygenation, respiratory mechanics Secondary outcome: Incidence of surgery related complications

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
April 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Università degli Studi di Ferrara
Responsible Party
Principal Investigator
Principal Investigator

Savino Spadaro

Researcher

Università degli Studi di Ferrara

Eligibility Criteria

Inclusion Criteria

  • patients undergoing elective abdominal, thoracic, vascular surgery
  • minimum age 18 years
  • informed consent

Exclusion Criteria

  • patients with severe cardiomyopathy or severe heart failure
  • history of coagulation disorders
  • patients with severe cardiovascular or respiratory disorders
  • renal insufficiency
  • severe liver diseases

Arms & Interventions

Cristalloid

group cristalloid (ringer lactate)

Intervention: Cristalloid administration

colloids

colloid: cristalloid in according to cardiac output

Intervention: Group Colloid

Outcomes

Primary Outcomes

effects on oxygenation, respiratory mechanics

Time Frame: every 30 minutes till the end of surgery

Lung compliance (l/cmH20), Airaway resistance (cmH2O/L/sec) and PaO2 will be measured

Secondary Outcomes

  • Incidence of respiratory complications(28 days)

Study Sites (1)

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