Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics

Università degli Studi di Ferrara

Status: Unknown

Conditions: Actual Impaired Fluid Volume; Mechanical Ventilation Complication

Treatments: Drug: Cristalloid administration; Drug: Group Colloid

Study type: Interventional

Funder types: Other

Identifiers

NCT02071524

22012014

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Cristalloid

Active Comparator group

Description:

group cristalloid (ringer lactate)

Treatment:

Drug: Cristalloid administration

colloids

Active Comparator group

Description:

colloid: cristalloid in according to cardiac output

Treatment:

Drug: Group Colloid