Clinical trial NCT03222271: iVAPS vs. S/T Modes as Non-invasive Weaning Strategy in COPD Patients
Official title: Intelligent Volume Assured Pressure Support (iVAPS) vs. Spontaneous/Timed Mode as Noninvasive Modes for Weaning of COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Exacerbation
Keywords: NIV weaning strategy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Success rate of either modes.
timeFrame: 48 hours
Secondary outcomes:
measure: Re-intubation rate in each group.
timeFrame: 30 days
measure: Mortality rate in each group
timeFrame: 30 days
measure: Duration spent on NIV
timeFrame: An average of 30 days
measure: Length of ICU stay
timeFrame: An average of 30 days
measure: Degree of patient's comfort
timeFrame: An average of 30 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
city: Assiut
country: Egypt
facility: Assiut University Hospital - RICU
Study officials:
affiliation: Assiut University
name: Suzan S Sayed, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: Aliaë A. Mohamed-Hussein, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Doaa M Magdy, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Sarah M Hamza, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: Talwar D, Dogra V. Weaning from mechanical ventilation in chronic obstructive pulmonary disease: Keys to success. J Assoc Chest Physicians 2016;4:43-9.
citation: 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.
citation: 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.