Acute Circulatory Failure During One-lung Ventilation SurgeryNCT02858115
Use of Mini-fluid Challenge for Fluid Responsiveness Prediction During One-lung Ventilation
An observational study of Acute Circulatory Failure During One-lung Ventilation Surgery, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
During thoracic surgery, an excessive use of fluid results in pulmonary complications. Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation. The investigators hypothesized that the assessment by transesophageal echocardiography (TEE) of subaortic velocity time index (VTI) variation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Circulatory Failure During One-lung Ventilation Surgery
- What is being tested?
- Fluid challenge and Trans-oesophageal echography
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Aug 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring one lung ventilation lung resection.
Who may be able to join
- Lung resection
- Acute circulatory failure
- One-lung ventilation
Who cannot join
- Sinusal rhythm
Trial locations and contacts
1 site in 1 country.
France1 site
hôpital Nord Assistance Publique Hôpitaux de Marseille
Marseille, 13015
About this study
During thoracic surgery, an excessive use of fluid results in pulmonary complications. Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation. The investigators hypothesized that the assessment by transesophageal echocardiography (TEE) of subaortic velocity time index (VTI) variation after 100 ml of crystalloid would predict fluid responsiveness in patients receiving one-lung ventilation.
This retrospective, observational, single center study was from January 2014 to December 2015. The investigators included 105 patients requiring one lung ventilation lung resection. The investigators analysed 39 patients presenting an acute circulatory failure. 100 ml of crystalloid was infused over 1-min. After an echocardiographic assessment at 1-min, remaining 400 ml were administered over 14-min Fluid responsiveness was defined as an increase in the VTI above 15% after infusion of 500 ml of crystalloid.
- Being tested
- Fluid challenge, Trans-oesophageal echography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challengeOther
100 ml of crystalloid was infused over 1-min
Trans-oesophageal echographyOther
an echocardiographic assessment at 1-min,
| Study group | Role | What they receive |
|---|---|---|
| one lung ventilation lung | patients requiring one lung ventilation lung resection. Receives: Other: Fluid challenge; Other: Trans-oesophageal echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness
increase of cardiac output of more than 15%
Measured: one day
Velocity time index
: Echographic assesment of cardiac output
Measured: one day
Secondary outcomes (1)
Pulsed pressure variation
dynamic indice of fluid responsiveness
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Circulatory Failure During One-lung Ventilation SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858115
- Sponsor's protocol ID
- 2014-30
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mini-fluid Challenge for Fluid Responsiveness Prediction During One-lung Ventilation
- ClinicalTrials.gov ID
- NCT02858115
- Acronym / sponsor ID
- 2014-30
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Aug 2016 (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.
During thoracic surgery, an excessive use of fluid results in pulmonary complications. Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation. The investigators hypothesized that the assessment by transesophageal echocardiography (TEE) of subaortic velocity time index (VTI) variation after 100 ml of crystalloid would predict fluid responsiveness in patients receiving one-lung ventilation.
This retrospective, observational, single center study was from January 2014 to December 2015. The investigators included 105 patients requiring one lung ventilation lung resection. The investigators analysed 39 patients presenting an acute circulatory failure. 100 ml of crystalloid was infused over 1-min. After an echocardiographic assessment at 1-min, remaining 400 ml were administered over 14-min Fluid responsiveness was defined as an increase in the VTI above 15% after infusion of 500 ml of crystalloid.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one lung ventilation lung | – | Other: Fluid challenge, Other: Trans-oesophageal echographypatients requiring one lung ventilation lung resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring one lung ventilation lung resection.
Key inclusion criteria (3 listed)
- Lung resection
- Acute circulatory failure
- One-lung ventilation
Key exclusion criteria (1 listed)
- Sinusal rhythm
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 |
|---|---|---|
| Fluid challenge100 ml of crystalloid was infused over 1-min | Other | one lung ventilation lung |
| Trans-oesophageal echographyan echocardiographic assessment at 1-min, | Other | one lung ventilation lung |
Primary outcome
Fluid responsiveness
Time frame: one day
increase of cardiac output of more than 15%
Velocity time index
Time frame: one day
: Echographic assesment of cardiac output
1 secondary outcome
Pulsed pressure variation
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Circulatory Failure During One-lung Ventilation Surgery, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 8 Aug 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid responsiveness (time frame: one day). The study lists 2 primary outcomes in all. 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 Aug 2016.