Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics

Not Applicable

• Conditions: Mechanical Ventilation Complication; Actual Impaired Fluid Volume
• Interventions: Drug: Cristalloid administration; Drug: Group Colloid

• Registration Number: NCT02071524
• Lead Sponsor: Università degli Studi di Ferrara

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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-26
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2016-11-08
• Primary Completion: 2017-03
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cristalloid	Cristalloid administration	group cristalloid (ringer lactate)
colloids	Group Colloid	colloid: cristalloid in according to cardiac output

Primary Outcome Measures

Name	Time	Method
effects on oxygenation, respiratory mechanics	every 30 minutes till the end of surgery	Lung compliance (l/cmH20), Airaway resistance (cmH2O/L/sec) and PaO2 will be measured

Secondary Outcome Measures

Name	Time	Method
Incidence of respiratory complications	28 days	Complications like acute respiratory failure, pneumonia and ARDS will be recorded

Trial Locations

Locations (1)

University of Ferrara; 🇮🇹 Ferrara, Italy