Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics

November 7, 2016 updated by: Savino Spadaro, Università degli Studi di Ferrara
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Savino Spadaro, researcher
  • Phone Number: +390532206570
  • Email: spdsvn@unife.it

Study Locations

  • Italy
      • Ferrara, Italy, 44121
        • Recruiting
        • University of Ferrara
        • Contact:
          • Carlo A Volta, professor
          • Phone Number: +390532206570
          • Email: vlc@unife.it
        • Principal Investigator:
          • Savino Spadaro, Researcher

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
  • severe liver diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cristalloid
group cristalloid (ringer lactate)
Drug: Cristalloid administration
Only Ringer Lactate administration
Active Comparator: colloids
colloid: cristalloid in according to cardiac output
Drug: Group Colloid
Group Colloid: cristalloid 1:2 (gelofusine: ringer lactate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every 30 minutes till the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of respiratory complications
Time Frame: 28 days
Complications like acute respiratory failure, pneumonia and ARDS will be recorded
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

February 21, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 22012014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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