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VSV Versus PSV as a Weaning Mode of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278795
Recruitment Status : Unknown
Verified September 2017 by Alaa Mohammed Taghyan, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Alaa Mohammed Taghyan, Assiut University

Brief Summary:
Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. Acute exacerbations may occur during the management of stable COPD which can negatively impact health status, rates of hospitalization and re-admission. During exacerbation, some patients need immediate admission to the respiratory intensive care unit (RICU) for ventilatory support. As prolonged mechanical ventilation has unfavourable impacts, it is Important to minimize the duration of mechanical ventilation and perform extubation as soon as possible. In recent years, development of numerous models of artificial respiration, which could support spontaneous breathing, has made it possible to gradually decrease the mechanical ventilatory support. From these new modes, PSV which is a well known weaning mode will be compared in our study to a new weaning mode which is a volume support ventilation (VSV).

Condition or disease Intervention/treatment Phase
COPD Procedure: pressure support ventilation mode Procedure: volume support ventilation mode Not Applicable

Detailed Description:

Acute exacerbations may occur during the management of stable COPD which can negatively impact health status, rates of hospitalization and re-admission. During exacerbation, some patients need immediate admission to the respiratory intensive care unit (RICU). Ventilatory support in an exacerbation can be provided by either noninvasive (nasal or facial mask) or invasive (oro-tracheal tube or tracheostomy) ventilation.

Mechanical ventilation may be complicated by barotrauma, volutrauma, and also unfavourable impacts on cardiovascular system and organ perfusion. Moreover, prolonged mechanical ventilation enhances the risk of nosocomial pneumonia. So it is Important to minimize the duration of mechanical ventilation and perform extubation as soon as possible. In recent years, development of numerous models of artificial respiration, which could support spontaneous breathing, has made it possible to gradually decrease the mechanical ventilatory support.

From these new modes, PSV (pressure-support ventilation) which is a well known weaning mode will be compared in our study to a new weaning mode which is a volume support ventilation (VSV).

VSV could be viewed as "PRVC for spontaneous breathing" as it delivers a variable pressure to meet a target VT.

  • The ventilator gives a test breath with an inspiratory pressure of 10 cmH2O above PEEP (5 cmH2O in earlier software versions)
  • It measures the volume delivered and calculates system Compliance
  • For each subsequent breath, the ventilator calculates compliance of the previous breath and adjusts the inspiratory pressure level (pressure level) to achieve the set VT on the next breath
  • The ventilator will not change the inspiratory pressure by more than 3 cm H2O from one breath to the next
  • Maximum available inspiratory pressure level is 5 cm H2O below the preset upper pressure limit (alarm will sound at this point and the breath will switch into exhalation)
  • The minimum pressure limit is the baseline setting (PEEP)
  • If apnea occurs, back up pressure control is activated and an alarm sounds
  • If Auto mode is on and patient becomes apneic, the mode will automatically switch to PRVC(pressure regulated volume control).

In PSV patients in whom a 8 cm H2O pressure support level could be achieved,a 2-h trial of spontaneous breathing with this pressure support level will performed before extubation .

In the VSV group, VT(tidal volume) will be adjusted at 6 ml/ Kg and If the patients showed good tolerance with an acceptable ABG (arterial blood gas)analysis (pH o7.35, PaO2(partial pressure of arterial oxygen)/FIO2 .150 with an FIO2(fraction of inspired oxygen) f 40%, RR (respiratory rate) f 35 breaths/min), they will ventilated for 2-h trial of spontaneous breathing and then extubated

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study group will be assigned to SIMV-VC for at least 48 hours . Patients will be assessed daily for fulfillment of criteria of readiness to wean according to European Respiratory Society guidelines (ERS guidelines ).

After fulfillment of ERS weaning criteria patients will be consequently divided into two equal groups: 1. 25 patients will be assigned to PSV weaning mode.

2. 25 patients will be assigned to VSV weaning mode. In PSV weaning group , PS will be adjusted 8 cm H2O. In VSV weaning group ,VT will be adjusted 6 ml/ Kg. Extubation will be done after successful spontaneous breathing trial according to ERS guidelines .

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Volume Support Ventilation Versus Pressure Support Ventilation as a Weaning Mode of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Active Comparator: PSV mode
PSV weaning group
Procedure: pressure support ventilation mode
PSV is the sole mode of mechanical ventilation and will be used as a weaning mode in mechanically ventilated chronic obstructive pulmonary disease patients,In PSV weaning group , PS(pressure support) will be adjusted at 8 cmH2O until 2-h successful spontaneous breathing trial parameters according to ERS(European Respiratory Society) guidelines will be achieved and then patient will ex-tubated.

Experimental: VSV mode
VSV weaning group
Procedure: volume support ventilation mode
VSV mode could be viewed as "PRVC for spontaneous breathing" as it delivers a variable pressure to meet a target VT. VSV will be used as a weaning mode in mechanically ventilated chronic obstructive pulmonary disease patients,In VSV weaning group ,VT(tidal volume ) will be adjusted at 6 ml/ Kg until 2-h successful spontaneous breathing trial parameters according to ERS guidelines will be achieved and then patient will ex-tubated.




Primary Outcome Measures :
  1. Success rate [ Time Frame: the first 48 hours after ex-tubation from mechanical ventilation . ]
    Assess success rate of PSV and VSV in weaning of COPD patients .Weaning success is defined as extubation and the absence of ventilatory support 48h following the extubation .


Secondary Outcome Measures :
  1. Detection of response to both modes [ Time Frame: the first 48 hours after ex-tubation from mechanical ventilation . ]
    if there was a decrease in the total weaning time ,assisted ventilation time and total time of mechanical ventilation .

  2. Number of weaning trials [ Time Frame: the first 48 hours after ex-tubation from mechanical ventilation . ]
    Detection of number of spontaneous breathing trials needed for weaning among both modes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All mechanically ventilated COPD patients at RICU.

Exclusion Criteria:

  • COPD patients associated bronchiectasis , interstitial lung disease and pneumonia.
  • Neurological and neuromuscular diseases hindering the respiratory drive.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278795


Contacts
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Contact: Maha Ghanem, Prof 00201227694434 mahaghanem@hotmail.com
Contact: Hoda Makhlouf, Prof 00201001529442 hamakhlouf@yahoo.com

Locations
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Egypt
Assiut University Hospital
Assiut, Egypt, Assiut University71515
Sponsors and Collaborators
Assiut University
Publications:
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Responsible Party: Alaa Mohammed Taghyan, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03278795    
Other Study ID Numbers: VSVVPSVAAWMOMVCOPDP
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alaa Mohammed Taghyan, Assiut University:
Weaning, ventilatory support, assisted ventilation modes
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases