Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics

Mechanical Ventilation Complication Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02071524
• Other study ID #: 22012014
• Status: Recruiting
• Phase: N/A
• First received: January 28, 2014
• Last updated: November 7, 2016
• Start date: September 2013
• Est. completion date: April 2017

Study information

• Verified date: November 2016
• Source: Università degli Studi di Ferrara
• Contact: Savino Spadaro, researcher
• Phone: +390532206570
• Email: spdsvn[@]unife.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Actual Impaired Fluid Volume
• Mechanical Ventilation Complication

Intervention

Drug:
• Group Colloid
Group Colloid: cristalloid 1:2 (gelofusine: ringer lactate)
• Cristalloid administration
Only Ringer Lactate administration

Locations

Country	Name	City	State
Italy	University of Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effects on oxygenation, respiratory mechanics	Lung compliance (l/cmH20), Airaway resistance (cmH2O/L/sec) and PaO2 will be measured	every 30 minutes till the end of surgery	Yes
Secondary	Incidence of respiratory complications	Complications like acute respiratory failure, pneumonia and ARDS will be recorded	28 days	Yes