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

Not Applicable

• Conditions: COPD
• Interventions: Procedure: pressure support ventilation mode; Procedure: volume support ventilation mode

• Registration Number: NCT03278795
• Lead Sponsor: 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).

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

Study Timeline

• Study First Submitted: 2017-08-25
• Status Verified: 2017-09
• Study Start: 2017-09
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13
• Primary Completion: 2018-09-01
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All mechanically ventilated COPD patients at RICU.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSV mode	pressure support ventilation mode	PSV weaning group
VSV mode	volume support ventilation mode	VSV weaning group

Primary Outcome Measures

Name	Time	Method
Success rate	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

Name	Time	Method
Number of weaning trials	the first 48 hours after ex-tubation from mechanical ventilation .	Detection of number of spontaneous breathing trials needed for weaning among both modes
Detection of response to both modes	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 .

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt