Echocardiographic Detection of Extravascular Lung Water Increase During Weaning From Mechanical Ventilation
ECHOBAG
1 other identifier
interventional
30
1 country
1
Brief Summary
Switching from positive airway pressure ventilation to spontaneous ventilation during weaning from mechanical ventilation, pulmonary edema may occur and in this case, doppler echocardiographic (U/S) indices of cardiac dysfunction correlates with the concentration of fluid in interstitial space. Forty consecutive mechanically ventilated critical ill patients who fulfill criteria for weaning from mechanical ventilation, will be included in this study. All patients will be evaluated daily and when the patients fulfill weaning criteria them they will undergo a 2-hour spontaneous breathing trial (SBT) through a T-piece. Before and after SBT cardiopulmonary function will be assessed by thermodilution and echocardiography. In patients with preserved LV systolic function, an echocardiographic index of diastolic dysfunction (E/Em ratio) before preforming SBT may identify high risk patients for increasing extravascular water in weaning. In addition, the investigators expect to find positive correlations (p\<0.05) between pulmonary extravascular lung water and echocardiographic indices (such as E/Em ratio) during SBT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 27, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedDecember 2, 2015
December 1, 2015
9 months
March 27, 2015
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Extravascular water increase during weaning from mechanical ventilation measured by echocardiography and thermodilution method
24 hours
Study Arms (1)
patients who undergo weaning from mechanical ventilation
OTHERconsecutive mechanically ventilated critical ill patients who fulfil criteria for weaning will be included
Interventions
Eligibility Criteria
You may qualify if:
- adequate oxygenation (pressure of oxygen in arterial blood (PaO2)\>60mmHg with fraction of inspired oxygen (FiO2)\<40%, PEEP\<5-10cmH2O, PaO2/FIO2\>150-300)
- stable cardiovascular system (Heart rate\<140/min, stable blood pressure, without or very minimal vasopressors)
- absence of sepsis and temperature \<38 degree of Celcius
- no respiratory acidosis
- adequate hemoglobin (Hb \> 8-10g/dL)
- sufficient (adequate mentation ) arousable Glasgow coma scale \>13/15, no continuous sedative infusions
- Ramsay score\<3
- stable metabolic status (acceptable levels of electrolytes )
- subjective clinical assessments such as resolution of the acute phase of disease and adequate cough.
You may not qualify if:
- atrial fibrillation or other arrhythmias
- insufficiency of tricuspidal valve ( +++),
- continuous venous-venous hemodialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Larissa
Larissa, Greece
Related Publications (6)
Kennedy SK, Weintraub RM, Skillman JJ. Cardiorespiratory and sympathoadrenal responses during weaning from controlled ventilation. Surgery. 1977 Aug;82(2):233-40.
PMID: 877867BACKGROUNDBuda AJ, Pinsky MR, Ingels NB Jr, Daughters GT 2nd, Stinson EB, Alderman EL. Effect of intrathoracic pressure on left ventricular performance. N Engl J Med. 1979 Aug 30;301(9):453-9. doi: 10.1056/NEJM197908303010901.
PMID: 460363BACKGROUNDHurford WE, Favorito F. Association of myocardial ischemia with failure to wean from mechanical ventilation. Crit Care Med. 1995 Sep;23(9):1475-80. doi: 10.1097/00003246-199509000-00006.
PMID: 7664548BACKGROUNDBoussuges A, Pinet C, Molenat F, Burnet H, Ambrosi P, Badier M, Sainty JM, Orehek J. Left atrial and ventricular filling in chronic obstructive pulmonary disease. An echocardiographic and Doppler study. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):670-5. doi: 10.1164/ajrccm.162.2.9908056.
PMID: 10934104BACKGROUNDRoutsi C, Stanopoulos I, Zakynthinos E, Politis P, Papas V, Zervakis D, Zakynthinos S. Nitroglycerin can facilitate weaning of difficult-to-wean chronic obstructive pulmonary disease patients: a prospective interventional non-randomized study. Crit Care. 2010;14(6):R204. doi: 10.1186/cc9326. Epub 2010 Nov 15.
PMID: 21078149BACKGROUNDIsakow W, Schuster DP. Extravascular lung water measurements and hemodynamic monitoring in the critically ill: bedside alternatives to the pulmonary artery catheter. Am J Physiol Lung Cell Mol Physiol. 2006 Dec;291(6):L1118-31. doi: 10.1152/ajplung.00277.2006. Epub 2006 Aug 4.
PMID: 16891389BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- AS. PROFESSOR
Study Record Dates
First Submitted
March 27, 2015
First Posted
April 9, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2015
Last Updated
December 2, 2015
Record last verified: 2015-12