iVAPS vs. S/T Modes as Non-invasive Weaning Strategy in COPD Patients

COPD Exacerbation Clinical Trial

Official title:

Intelligent Volume Assured Pressure Support (iVAPS) vs. Spontaneous/Timed Mode as Noninvasive Modes for Weaning of COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222271
• Other study ID #: IVAPSSTMNMWCP
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

Device:
• Extubation to NIV
Weaning using NIV immediately after extubation with the mentioned parameters

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut
Egypt	Assiut University Hospital - RICU	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. Epub 2007 Feb 24. — View 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. Review. — View Citation

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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours
Secondary	Re-intubation rate in each group.	Measured by number of the patients re-intubated in each arm	30 days
Secondary	Mortality rate in each group	Measured by number of the patients re-intubated in each arm	30 days
Secondary	Duration spent on NIV	Measured in days	An average of 30 days
Secondary	Length of ICU stay	Measured in days	An average of 30 days
Secondary	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.	An average of 30 days