NCT02412202

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

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

March 27, 2015

Last Update Submit

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

OTHER

consecutive mechanically ventilated critical ill patients who fulfil criteria for weaning will be included

Other: Monitoring of pulmonary oedema induced by weaning from mechanical ventilation

Interventions

patients who undergo weaning from mechanical ventilation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 877867BACKGROUND
  • Buda 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: 460363BACKGROUND
  • Hurford 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: 7664548BACKGROUND
  • Boussuges 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: 10934104BACKGROUND
  • Routsi 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: 21078149BACKGROUND
  • Isakow 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

Locations