Mechanical Ventilation ComplicationNCT02071524
Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics
A study testing Group Colloid and Cristalloid administration in people with Mechanical Ventilation Complication and Actual Impaired Fluid Volume, run by Università degli Studi di Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mechanical Ventilation Complication, Actual Impaired Fluid Volume
- What is being tested?
- Group Colloid and Cristalloid administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective abdominal, thoracic, vascular surgery
- minimum age 18 years
- informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Ferrara
Ferrara, 44121
Carlo A Volta, professor, +390532206570, vlc@unife.it
Savino Spadaro, Researcher
About this study
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.
Read the 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
- Being tested
- Group Colloid, Cristalloid administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ColloidDrug
Group Colloid: cristalloid 1:2 (gelofusine: ringer lactate)
Cristalloid administrationDrug
Only Ringer Lactate administration
| Study group | Role | What they receive |
|---|---|---|
| Cristalloid | Active comparator | group cristalloid (ringer lactate) Receives: Drug: Cristalloid administration |
| colloids | Active comparator | colloid: cristalloid in according to cardiac output Receives: Drug: Group Colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects on oxygenation, respiratory mechanics
Lung compliance (l/cmH20), Airaway resistance (cmH2O/L/sec) and PaO2 will be measured
Measured: every 30 minutes till the end of surgery
Secondary outcomes (1)
Incidence of respiratory complications
Complications like acute respiratory failure, pneumonia and ARDS will be recorded
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savino Spadaro, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071524
- Sponsor's protocol ID
- 22012014
- Status last verified
- Nov 2016
- First submitted
- 28 Jan 2014
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics
- ClinicalTrials.gov ID
- NCT02071524
- Acronym / sponsor ID
- 22012014
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cristalloid | Active comparator | Drug: Cristalloid administrationgroup cristalloid (ringer lactate) |
| colloids | Active comparator | Drug: Group Colloidcolloid: cristalloid in according to cardiac output |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing elective abdominal, thoracic, vascular surgery
- minimum age 18 years
- informed consent
Key exclusion criteria (5 listed)
- patients with severe cardiomyopathy or severe heart failure
- history of coagulation disorders
- patients with severe cardiovascular or respiratory disorders
- renal insufficiency
- severe liver diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group ColloidGroup Colloid: cristalloid 1:2 (gelofusine: ringer lactate) | Drug | colloids |
| Cristalloid administrationOnly Ringer Lactate administration | Drug | Cristalloid |
Primary outcome
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
1 secondary outcome
Incidence of respiratory complications
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Colloid and Cristalloid administration in people with Mechanical Ventilation Complication and Actual Impaired Fluid Volume, run by Università degli Studi di Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Savino Spadaro, researcher (+390532206570, spdsvn@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects on oxygenation, respiratory mechanics (time frame: every 30 minutes till the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.