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Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02071524
Enrollment
40
Registered
2014-02-26
Start date
2013-09-30
Completion date
2017-04-30
Last updated
2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actual Impaired Fluid Volume, Mechanical Ventilation Complication

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

Interventions

DRUGGroup Colloid

Group Colloid: cristalloid 1:2 (gelofusine: ringer lactate)

DRUGCristalloid administration

Only Ringer Lactate administration

Sponsors

Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
effects on oxygenation, respiratory mechanicsevery 30 minutes till the end of surgeryLung compliance (l/cmH20), Airaway resistance (cmH2O/L/sec) and PaO2 will be measured

Secondary

MeasureTime frameDescription
Incidence of respiratory complications28 daysComplications like acute respiratory failure, pneumonia and ARDS will be recorded

Countries

Italy

Contacts

Primary ContactSavino Spadaro, researcher
spdsvn@unife.it+390532206570

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026