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

NCT03278795 | Unknown

• 1 other identifier: VSVVPSVAAWMOMVCOPDP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

COPD

Keywords

Weaning, ventilatory support, assisted ventilation modes

Outcome Measures

Primary Outcomes (1)

• Success rate

  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 .

  the first 48 hours after ex-tubation from mechanical ventilation .

Secondary Outcomes (2)

• Detection of response to both modes

  the first 48 hours after ex-tubation from mechanical ventilation .

• Number of weaning trials

  the first 48 hours after ex-tubation from mechanical ventilation .

Study Arms (2)

PSV mode

ACTIVE COMPARATOR

PSV weaning group

Procedure: pressure support ventilation mode

VSV mode

EXPERIMENTAL

VSV weaning group

Procedure: volume support ventilation mode

Interventions

pressure support ventilation mode PROCEDURE

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.

PSV mode

volume support ventilation mode PROCEDURE

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.

VSV mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All mechanically ventilated COPD patients at RICU.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Assiut University71515, Egypt

Location

Related Publications (4)

• Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J. 2009 May;33(5):1165-85. doi: 10.1183/09031936.00128008.

  PMID: 19407051 BACKGROUND

• Sancar NK, Ozcan PE, Senturk E, Selek C, Cakar N. The Comparison of Pressure (PSV) and Volume Support Ventilation (VSV) as a 'Weaning' Mode. Turk J Anaesthesiol Reanim. 2014 Aug;42(4):170-5. doi: 10.5152/TJAR.2014.61687. Epub 2014 May 29.

  PMID: 27366416 BACKGROUND

• Ruiz-Santana S, Garcia Jimenez A, Esteban A, Guerra L, Alvarez B, Corcia S, Gudin J, Martinez A, Quintana E, Armengol S, et al. ICU pneumonias: a multi-institutional study. Crit Care Med. 1987 Oct;15(10):930-2. doi: 10.1097/00003246-198710000-00007.

  PMID: 3652708 BACKGROUND

• Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.

  PMID: 17470624 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maha Ghanem, Prof

CONTACT

00201227694434; mahaghanem@hotmail.com

Hoda Makhlouf, Prof

CONTACT

00201001529442; hamakhlouf@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 .

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: September 12, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: March 1, 2020
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)