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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02858115
Other study ID # 2014-30
Secondary ID
Status Completed
Phase N/A
First received August 3, 2016
Last updated August 5, 2016
Start date January 2014
Est. completion date August 2016

Study information

Verified date August 2016
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Lung resection

- Acute circulatory failure

- One-lung ventilation

Exclusion Criteria:

- Sinusal rhythm

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms

  • Acute Circulatory Failure During One-lung Ventilation Surgery
  • Shock

Intervention

Other:
Fluid challenge
100 ml of crystalloid was infused over 1-min
Trans-oesophageal echography
an echocardiographic assessment at 1-min,

Locations

Country Name City State
France hôpital Nord Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fluid responsiveness increase of cardiac output of more than 15% one day No
Primary Velocity time index : Echographic assesment of cardiac output one day No
Secondary Pulsed pressure variation dynamic indice of fluid responsiveness one day No