- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03222271
iVAPS vs. S/T Modes as Non-invasive Weaning Strategy in COPD Patients
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.
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt, Assiut university 71515
- Assiut university hospital
-
Assiut, Egypt
- Assiut University Hospital - RICU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All patients in acute exacerbation of COPD who are mechanically ventilated will be included in this study.
Exclusion Criteria:
- Age < 18 years or >75 years.
- Other chest diseases (pneumonia, bronchiectasis, pulmonary embolism, pulmonary fibrosis…).
- Tracheostomized patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: I) Extubation to NIV (S/T mode)
The patients will receive NIV using S/T mode after extubation with the following parameters:
|
Weaning using NIV immediately after extubation with the mentioned parameters
Other Names:
|
Experimental: II) Extubation to NIV (iVAPS) mode
The patients will receive NIV using iVAPS mode after extubation with the following parameters:
|
Weaning using NIV immediately after extubation with the mentioned parameters
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Re-intubation rate in each group.
Time Frame: 30 days
|
Measured by number of the patients re-intubated in each arm
|
30 days
|
Mortality rate in each group
Time Frame: 30 days
|
Measured by number of the patients re-intubated in each arm
|
30 days
|
Duration spent on NIV
Time Frame: An average of 30 days
|
Measured in days
|
An average of 30 days
|
Length of ICU stay
Time Frame: An average of 30 days
|
Measured in days
|
An average of 30 days
|
Degree of patient's comfort
Time Frame: An average of 30 days
|
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.
|
An average of 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Suzan S Sayed, MD, Assiut University
- Study Director: Aliaë A. Mohamed-Hussein, MD, Assiut University
- Study Director: Doaa M Magdy, MD, Assiut University
- Principal Investigator: Sarah M Hamza, MSc, Assiut University
Publications and helpful links
General 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.
- Burns 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.
- Talwar 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.
- Battisti 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IVAPSSTMNMWCP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD Exacerbation
-
University Medical Center GroningenCompleted
-
Sociedad Española de Neumología y Cirugía TorácicaGlaxoSmithKlineNot yet recruitingCOPD Exacerbation
-
University of Tennessee Graduate School of MedicineMylan Pharmaceuticals IncRecruiting
-
Malcolm KohlerDeep Breath Intelligence (DBI)RecruitingCOPD ExacerbationSwitzerland
-
Universidad Autonoma de MadridCompleted
-
Guy's and St Thomas' NHS Foundation TrustCompleted
-
Hospital Universitario Marqués de ValdecillaGlaxoSmithKlineUnknown
-
Hospital Universitario Marqués de ValdecillaRecruiting
-
Ottawa Hospital Research InstituteCompleted
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI)CompletedCOPD ExacerbationUnited States
Clinical Trials on Extubation to NIV
-
Hospital Virgen de la SaludCompleted
-
Women and Infants Hospital of Rhode IslandCompletedBronchopulmonary DysplasiaUnited States
-
University of Southern CaliforniaDey, L.P., Napa Valley, CalifoniaCompletedRespiratory Distress Syndrome, NewbornUnited States
-
McMaster UniversityUnknown
-
Centro Hospitalar Unimed de JoinvilleRecruitingAirway Extubation | Ventilator WeaningBrazil
-
Chinese University of Hong KongThe Queen Elizabeth HospitalUnknown
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)Enrolling by invitationAirway Extubation | Acute Respiratory FailureUnited States
-
Fondazione Don Carlo Gnocchi OnlusFondazione Salvatore MaugeriCompleted
-
Nantes University HospitalCompletedBrain InjuriesFrance, India, Italy, Netherlands
-
Rennes University HospitalRecruitingChronic Obstructive Pulmonary Disease (COPD) | Obesity With a BMI Greater Than 30 | Acute Respiratory Distress in Adult Intensive CareFrance