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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03222271
Enrollment
80
Registered
2017-07-19
Start date
2017-10-25
Completion date
2020-09-30
Last updated
2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

Keywords

NIV weaning strategy

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.

Interventions

DEVICEExtubation to NIV

Weaning using NIV immediately after extubation with the mentioned parameters

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Success rate of either modes.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

Secondary

MeasureTime frameDescription
Re-intubation rate in each group.30 daysMeasured by number of the patients re-intubated in each arm
Mortality rate in each group30 daysMeasured by number of the patients re-intubated in each arm
Duration spent on NIVAn average of 30 daysMeasured in days
Length of ICU stayAn average of 30 daysMeasured in days
Degree of patient's comfortAn average of 30 daysA 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026