COPD ExacerbationNCT03222271
iVAPS vs. S/T Modes as Non-invasive Weaning Strategy in COPD Patients
A study testing Extubation to NIV in people with COPD Exacerbation, run by Assiut University at 2 sites in Egypt.
Trial summary
Invasive mechanical ventilation (IMV) is associated with numerous complications. Hence, patients should be weaned from the ventilator as early as possible. A number of randomized controlled trials have addressed whether noninvasive ventilation (NIV) can facilitate weaning in patients failing spontaneous breathing… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Extubation to NIV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Oct 2017to 30 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients in acute exacerbation of COPD who are mechanically ventilated will be included in this study.
Who cannot join
- Age < 18 years or >75 years.
- Other chest diseases (pneumonia, bronchiectasis, pulmonary embolism, pulmonary fibrosis…).
- Tracheostomized patients.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assiut University Hospital
Asyut, Assiut University 71515
Assiut University Hospital - RICU
Asyut
About this study
Official title: Intelligent Volume Assured Pressure Support (iVAPS) vs. Spontaneous/Timed Mode as Noninvasive Modes for Weaning of COPD Patients
Invasive mechanical ventilation (IMV) is associated with numerous complications. Hence, patients should be weaned from the ventilator as early as possible. A number of randomized controlled trials have addressed whether noninvasive ventilation (NIV) can facilitate weaning in patients failing spontaneous breathing trials (SBT)s. Compared to invasive weaning, NIV weaning strategy showed reduced mortality, greater weaning success, less ventilator-associated pneumonia, shorter length of ICU and hospital stay and less re-intubation rate.
Most of the previous studies used pressure support ventilation with fixed pressure support, but no studies published on hybrid NIV modes.
Read more
Intelligent Volume Assured Pressure Support (iVAPS) is a recent NIV mode, which achieves a target alveolar ventilation by adjusting pressure support and respiratory rate automatically. In iVAPS, the target is alveolar ventilation not the tidal volume, taking into account a predicted dead space . This new mode has been investigated in stable chronic obstructive pulmonary disease (COPD) patients with domiciliary NIV and it was comparable to pressure support ventilation (PSV) regarding improvement in oxygenation, carbon dioxide (CO2) wash and therapy compliance.
Yet, less numerous studies have been performed on this mode when used for acute respiratory failure. These studies found that i-VAPS was comparable to PSV as regards PaCO2 and pH improvements, minute volume, pressure support and respiratory rate. No published data so far about the role of i-VAPS as a weaning mode in mechanically ventilated patients. So, this study aims to investigate this new mode in comparison to the standard S/T mode in weaning COPD patients using NIV.
Read the detailed description
Invasive mechanical ventilation (IMV) is associated with numerous complications. Hence, patients should be weaned from the ventilator as early as possible . Approximately 25% and (14-22) % of mechanically ventilated patients experience difficult and prolonged weaning respectively. A number of randomized controlled trials have addressed whether NIV can facilitate weaning in patients failing SBTs. The most recent systemic review included 16 trials -mainly COPD patients- found that patients weaned with NIV had reduced mortality, greater weaning success, less ventilator-associated pneumonia, shorter length of ICU and hospital stay and less reintubation rate.
Most of the previous studies used pressure support ventilation with fixed pressure support, but no studies published on hybrid NIV modes. Intelligent Volume Assured Pressure Support (iVAPS) is a recent NIV mode, which achieves a target alveolar volume by adjusting pressure and respiratory rate automatically. In iVAPS, the target is alveolar ventilation not the tidal volume. taking into account a predicted dead space. This new mode has been investigated in stable COPD patients with domiciliary NIV and it was comparable to pressure support ventilation (PSV) regarding improvement in oxygenation, CO2 wash and therapy compliance. Other studies focused on sleep quality and found that iVAPS was comparable to PSV regarding sleep quality, arousal, O2 de-saturation index, increase in therapy adherence and decrease in median PS needed with iVAPS.
Yet, less numerous studies have been performed on this mode when used for acute respiratory failure. These studies investigated the outcomes in acute hypercapnic respiratory failure and found that iVAPS was comparable to PSV as regards PaCO2 and logarithm of hydrogen ion concentration (pH) improvements, minute volume, pressure support and respiratory rate. No published data about the role of iVAPS as a weaning mode in mechanically ventilated patients.
- Conditions
- COPD Exacerbation
- Being tested
- Extubation to NIV
- Keywords
- NIV weaning strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extubation to NIVDevice
Also called NIV portable device: Res MED(S9 VPAPTM ST)
Weaning using NIV immediately after extubation with the mentioned parameters
| Study group | Role | What they receive |
|---|---|---|
| I) Extubation to NIV (S/T mode) | Active comparator | The patients will receive NIV using S/T mode after extubation with the following parameters:
* Expiratory Positive Airway Pressure (EPAP): 4-8 centimeter water (cmH2O).
* Inspiratory Positive Airway Pressure (IPAP): 12-20 cmH2O.
* Respiratory rate (RR): 10-12 breath/minute. Receives: Device: Extubation to NIV |
| II) Extubation to NIV (iVAPS) mode | Experimental | The patients will receive NIV using iVAPS mode after extubation with the following parameters:
* Patient's height in cm..
* Target alveolar ventilation (Va): adjusted provided that tidal volume is 8 ml/kg of ideal body weight (IBW).
* Expiratory Positive Airway Pressure (EPAP) :4-8 cmH2O
* Minimum and maximum Pressure Support (PS) :8-16
* Respiratory rate :10-12 breath/min. Receives: Device: Extubation to NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of either modes.
-Success is considered when the patient is able to achieve the following: pH >7.35,decrease in partial pressure of carbon dioxide (PaCO2) of >15-20%, partial pressure of oxygen (PaO2)>60 mmHg, arterial oxygen saturation (SaO2)> 90% on fraction of inspired oxygen (FiO2) <40%, RR < 24 bpm and no signs of respiratory distress like agitation, diaphoresis or anxiety.
Numbers of successful cases is recorded
Measured: 48 hours
Secondary outcomes (5)
Re-intubation rate in each group.
Measured by number of the patients re-intubated in each arm
Measured: 30 days
Mortality rate in each group
Measured by number of the patients re-intubated in each arm
Measured: 30 days
Duration spent on NIV
Measured in days
Measured: An average of 30 days
Length of ICU stay
Measured in days
Measured: An average of 30 days
Degree of patient's comfort
A specific questionnaire (pain in the forehead, nose, cheeks, and chin, air leak at eyes and mouth, dry nose and mouth, skin inflammation and claustrophobia. The patients answers to each question (sore0-3 in terms of intensity). The total score is calculated by adding the individual scores of each item mentioned above.
Measured: An average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start25 Oct 2017
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will be subjected to history and clinical examination,severity assessment(mMRC dyspnea scale,APACHE II Score and CAT score). A) Extubation to NIV: SBT will be attempted once the patients achieve stability regarding clinical, neurological and biochemical parameters.Failure of SBT is considered if:pH \< 7.35,PaCO2 \> 15-20% increase above baseline,PaO2 \< 50 mmHg.Heart rate \> 100 bpm or respiratory rate \> 35 cycle/min. * RSBI and P 0.1. will be recorded while on SBT B) The patients will be randomized to receive NIV using either ST or iVAPS mode. C) The patients will be categorized in analysis into 3 groups,Group I: Simple weaning ,Group II: Difficult weaning and Group III: Prolonged weaning. -The following parameters will be recorded for the patients at the beginning of the study and at 1, 2, 12, 24 and 48 hours after initiation of NIV therapy:GCS,Vital signs (HR, SBP\& DBP,RR), ABG analysis and Patient's comfort.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mohammed Hashem Hamza Ahmed, Assiut University
- Investigators
- Suzan S Sayed, MD, Study chair, Assiut UniversityAliaë A. Mohamed-Hussein, MD, Study director, Assiut UniversityDoaa M Magdy, MD, Study director, Assiut UniversitySarah M Hamza, MSc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222271
- Sponsor's protocol ID
- IVAPSSTMNMWCP
- Status last verified
- Jan 2021
- First submitted
- 13 Jul 2017
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Funk GC, Anders S, Breyer MK, Burghuber OC, Edelmann G, Heindl W, Hinterholzer G, Kohansal R, Schuster R, Schwarzmaier-D'Assie A, Valentin A, Hartl S. Incidence and outcome of weaning from mechanical ventilation according to new categories. Eur Respir J. 2010 Jan;35(1):88-94. doi: 10.1183/09031936.00056909. Epub 2009 Jun 18.
PubMed 19541716Burns KE, Meade MO, Premji A, Adhikari NK. Noninvasive ventilation as a weaning strategy for mechanical ventilation in adults with respiratory failure: a Cochrane systematic review. CMAJ. 2014 Feb 18;186(3):E112-22. doi: 10.1503/cmaj.130974. Epub 2013 Dec 9.
PubMed 24324020Talwar D, Dogra V. Weaning from mechanical ventilation in chronic obstructive pulmonary disease: Keys to success. J Assoc Chest Physicians 2016;4:43-9.
Kelly JL, Jaye J, Pickersgill RE, Chatwin M, Morrell MJ, Simonds AK. Randomized trial of 'intelligent' autotitrating ventilation versus standard pressure support non-invasive ventilation: impact on adherence and physiological outcomes. Respirology. 2014 May;19(4):596-603. doi: 10.1111/resp.12269. Epub 2014 Mar 24.
PubMed 24661390Battisti A, Tassaux D, Bassin D, Jolliet P. Automatic adjustment of noninvasive pressure support with a bilevel home ventilator in patients with acute respiratory failure: a feasibility study. Intensive Care Med. 2007 Apr;33(4):632-8. doi: 10.1007/s00134-007-0550-1. Epub 2007 Feb 24.
PubMed 17323049
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Volume Assured Pressure Support (iVAPS) vs. Spontaneous/Timed Mode as Noninvasive Modes for Weaning of COPD Patients
- ClinicalTrials.gov ID
- NCT03222271
- Acronym / sponsor ID
- IVAPSSTMNMWCP
- Conditions
- COPD Exacerbation
- Keywords
- NIV weaning strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 19 Jul 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.
Invasive mechanical ventilation (IMV) is associated with numerous complications. Hence, patients should be weaned from the ventilator as early as possible. A number of randomized controlled trials have addressed whether noninvasive ventilation (NIV) can facilitate weaning in patients failing spontaneous breathing trials (SBT)s. Compared to invasive weaning, NIV weaning strategy showed reduced mortality, greater weaning success, less ventilator-associated pneumonia, shorter length of ICU and hospital stay and less re-intubation rate.
Most of the previous studies used pressure support ventilation with fixed pressure support, but no studies published on hybrid NIV modes.
Intelligent Volume Assured Pressure Support (iVAPS) is a recent NIV mode, which achieves a target alveolar ventilation by adjusting pressure support and respiratory rate automatically. In iVAPS, the target is alveolar ventilation not the tidal volume, taking into account a predicted dead space . This new mode has been investigated in stable chronic obstructive pulmonary disease (COPD) patients with domiciliary NIV and it was comparable to pressure support ventilation (PSV) regarding improvement in oxygenation, carbon dioxide (CO2) wash and therapy compliance.
Yet, less numerous studies have been performed on this mode when used for acute respiratory failure. These studies found that i-VAPS was comparable to PSV as regards PaCO2 and pH improvements, minute volume, pressure support and respiratory rate. No published data so far about the role of i-VAPS as a weaning mode in mechanically ventilated patients. So, this study aims to investigate this new mode in comparison to the standard S/T mode in weaning COPD patients using NIV.
Detailed description
Invasive mechanical ventilation (IMV) is associated with numerous complications. Hence, patients should be weaned from the ventilator as early as possible . Approximately 25% and (14-22) % of mechanically ventilated patients experience difficult and prolonged weaning respectively. A number of randomized controlled trials have addressed whether NIV can facilitate weaning in patients failing SBTs. The most recent systemic review included 16 trials -mainly COPD patients- found that patients weaned with NIV had reduced mortality, greater weaning success, less ventilator-associated pneumonia, shorter length of ICU and hospital stay and less reintubation rate.
Most of the previous studies used pressure support ventilation with fixed pressure support, but no studies published on hybrid NIV modes. Intelligent Volume Assured Pressure Support (iVAPS) is a recent NIV mode, which achieves a target alveolar volume by adjusting pressure and respiratory rate automatically. In iVAPS, the target is alveolar ventilation not the tidal volume. taking into account a predicted dead space. This new mode has been investigated in stable COPD patients with domiciliary NIV and it was comparable to pressure support ventilation (PSV) regarding improvement in oxygenation, CO2 wash and therapy compliance. Other studies focused on sleep quality and found that iVAPS was comparable to PSV regarding sleep quality, arousal, O2 de-saturation index, increase in therapy adherence and decrease in median PS needed with iVAPS.
Yet, less numerous studies have been performed on this mode when used for acute respiratory failure. These studies investigated the outcomes in acute hypercapnic respiratory failure and found that iVAPS was comparable to PSV as regards PaCO2 and logarithm of hydrogen ion concentration (pH) improvements, minute volume, pressure support and respiratory rate. No published data about the role of iVAPS as a weaning mode in mechanically ventilated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All patients will be subjected to history and clinical examination,severity assessment(mMRC dyspnea scale,APACHE II Score and CAT score). A) Extubation to NIV: SBT will be attempted once the patients achieve stability regarding clinical, neurological and biochemical parameters.Failure of SBT is considered if:pH < 7.35,PaCO2 > 15-20% increase above baseline,PaO2 < 50 mmHg.Heart rate > 100 bpm or respiratory rate > 35 cycle/min. * RSBI and P 0.1. will be recorded while on SBT B) The patients will be randomized to receive NIV using either ST or iVAPS mode. C) The patients will be categorized in analysis into 3 groups,Group I: Simple weaning ,Group II: Difficult weaning and Group III: Prolonged weaning. -The following parameters will be recorded for the patients at the beginning of the study and at 1, 2, 12, 24 and 48 hours after initiation of NIV therapy:GCS,Vital signs (HR, SBP\& DBP,RR), ABG analysis and Patient's comfort.
| Arm | Type | Receives |
|---|---|---|
| I) Extubation to NIV (S/T mode) | Active comparator | Device: Extubation to NIVThe patients will receive NIV using S/T mode after extubation with the following parameters: * Expiratory Positive Airway Pressure (EPAP): 4-8 centimeter water (cmH2O). * Inspiratory Positive Airway Pressure (IPAP): 12-20 cmH2O. * Respiratory rate (RR): 10-12 breath/minute. |
| II) Extubation to NIV (iVAPS) mode | Experimental | Device: Extubation to NIVThe patients will receive NIV using iVAPS mode after extubation with the following parameters: * Patient's height in cm.. * Target alveolar ventilation (Va): adjusted provided that tidal volume is 8 ml/kg of ideal body weight (IBW). * Expiratory Positive Airway Pressure (EPAP) :4-8 cmH2O * Minimum and maximum Pressure Support (PS) :8-16 * Respiratory rate :10-12 breath/min. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients in acute exacerbation of COPD who are mechanically ventilated will be included in this study.
Key exclusion criteria (3 listed)
- Age < 18 years or >75 years.
- Other chest diseases (pneumonia, bronchiectasis, pulmonary embolism, pulmonary fibrosis…).
- Tracheostomized patients.
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 |
|---|---|---|
| Extubation to NIVAlso: NIV portable device: Res MED(S9 VPAPTM ST)Weaning using NIV immediately after extubation with the mentioned parameters | Device | I) Extubation to NIV (S/T mode), II) Extubation to NIV (iVAPS) mode |
Primary outcome
Success rate of either modes.
Time frame: 48 hours
-Success is considered when the patient is able to achieve the following: pH >7.35,decrease in partial pressure of carbon dioxide (PaCO2) of >15-20%, partial pressure of oxygen (PaO2)>60 mmHg, arterial oxygen saturation (SaO2)> 90% on fraction of inspired oxygen (FiO2) <40%, RR < 24 bpm and no signs of respiratory distress like agitation, diaphoresis or anxiety. Numbers of successful cases is recorded
5 secondary outcomes
Re-intubation rate in each group.
Time frame: 30 days
Mortality rate in each group
Time frame: 30 days
Duration spent on NIV
Time frame: An average of 30 days
Length of ICU stay
Time frame: An average of 30 days
Degree of patient's comfort
Time frame: An average of 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 19541716Funk GC, Anders S, Breyer MK, Burghuber OC, Edelmann G, Heindl W, Hinterholzer G, Kohansal R, Schuster R, Schwarzmaier-D'Assie A, Valentin A, Hartl S. Incidence and outcome of weaning from mechanical ventilation according to new categories. Eur Respir J. 2010 Jan;35(1):88-94. doi: 10.1183/09031936.00056909. Epub 2009 Jun 18.
- Background: PubMed 24324020Burns KE, Meade MO, Premji A, Adhikari NK. Noninvasive ventilation as a weaning strategy for mechanical ventilation in adults with respiratory failure: a Cochrane systematic review. CMAJ. 2014 Feb 18;186(3):E112-22. doi: 10.1503/cmaj.130974. Epub 2013 Dec 9.
- BackgroundTalwar D, Dogra V. Weaning from mechanical ventilation in chronic obstructive pulmonary disease: Keys to success. J Assoc Chest Physicians 2016;4:43-9.
- Background: PubMed 24661390Kelly JL, Jaye J, Pickersgill RE, Chatwin M, Morrell MJ, Simonds AK. Randomized trial of 'intelligent' autotitrating ventilation versus standard pressure support non-invasive ventilation: impact on adherence and physiological outcomes. Respirology. 2014 May;19(4):596-603. doi: 10.1111/resp.12269. Epub 2014 Mar 24.
- Background: PubMed 17323049Battisti A, Tassaux D, Bassin D, Jolliet P. Automatic adjustment of noninvasive pressure support with a bilevel home ventilator in patients with acute respiratory failure: a feasibility study. Intensive Care Med. 2007 Apr;33(4):632-8. doi: 10.1007/s00134-007-0550-1. Epub 2007 Feb 24.
- 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.
Suzan S Sayed, MD study chair
Assiut University
Aliaë A. Mohamed-Hussein, MD study director
Assiut University
Doaa M Magdy, MD study director
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extubation to NIV in people with COPD Exacerbation, run by Assiut University at 2 sites 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 3 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: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of either modes. (time frame: 48 hours). 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 NCT03222271, which also lists 5 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 Jan 2021.