COPDNCT03278795
VSV Versus PSV as a Weaning Mode of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
A study testing pressure support ventilation mode and volume support ventilation mode in people with COPD, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- pressure support ventilation mode and volume support ventilation mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2017to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All mechanically ventilated COPD patients at RICU.
Who cannot join
- COPD patients associated bronchiectasis , interstitial lung disease and pneumonia.
- Neurological and neuromuscular diseases hindering the respiratory drive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Volume Support Ventilation Versus Pressure Support Ventilation as a Weaning Mode of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
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).
Read the 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
- Conditions
- COPD
- Being tested
- pressure support ventilation mode, volume support ventilation mode
- Keywords
- Weaning, ventilatory support, assisted ventilation modes
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure support ventilation modeProcedure or surgery
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.
volume support ventilation modeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PSV mode | Active comparator | PSV weaning group Receives: Procedure: pressure support ventilation mode |
| VSV mode | Experimental | VSV weaning group Receives: Procedure: volume support ventilation mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: the first 48 hours after ex-tubation from mechanical ventilation .
Secondary outcomes (2)
Detection of response to both modes
if there was a decrease in the total weaning time ,assisted ventilation time and total time of mechanical ventilation .
Measured: the first 48 hours after ex-tubation from mechanical ventilation .
Number of weaning trials
Detection of number of spontaneous breathing trials needed for weaning among both modes
Measured: the first 48 hours after ex-tubation from mechanical ventilation .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startSep 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohammed Taghyan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278795
- Sponsor's protocol ID
- VSVVPSVAAWMOMVCOPDP
- Status last verified
- Sep 2017
- First submitted
- 25 Aug 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J. 2009 May;33(5):1165-85. doi: 10.1183/09031936.00128008.
PubMed 19407051Sancar 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.
PubMed 27366416Ruiz-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.
PubMed 3652708Boles 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.
PubMed 17470624
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Support Ventilation Versus Pressure Support Ventilation as a Weaning Mode of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT03278795
- Acronym / sponsor ID
- VSVVPSVAAWMOMVCOPDP
- Conditions
- COPD
- Keywords
- Weaning, ventilatory support, assisted ventilation modes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 .
| Arm | Type | Receives |
|---|---|---|
| PSV mode | Active comparator | Procedure: pressure support ventilation modePSV weaning group |
| VSV mode | Experimental | Procedure: volume support ventilation modeVSV weaning group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All mechanically ventilated COPD patients at RICU.
Key exclusion criteria (2 listed)
- COPD patients associated bronchiectasis , interstitial lung disease and pneumonia.
- Neurological and neuromuscular diseases hindering the respiratory drive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pressure support ventilation modePSV 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. | Procedure or surgery | PSV mode |
| volume support ventilation modeVSV 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. | Procedure or surgery | VSV mode |
Primary outcome
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 .
2 secondary outcomes
Detection of response to both modes
Time frame: the first 48 hours after ex-tubation from mechanical ventilation .
Number of weaning trials
Time frame: the first 48 hours after ex-tubation from mechanical ventilation .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Background: PubMed 19407051Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J. 2009 May;33(5):1165-85. doi: 10.1183/09031936.00128008.
- Background: PubMed 27366416Sancar 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.
- Background: PubMed 3652708Ruiz-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.
- Background: PubMed 17470624Boles 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pressure support ventilation mode and volume support ventilation mode in people with COPD, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Ghanem, Prof (00201227694434, mahaghanem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: the first 48 hours after ex-tubation from mechanical ventilation .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03278795, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.