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

NCT03222271 | Completed

• 1 other identifier: IVAPSSTMNMWCP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD Exacerbation

Keywords

NIV weaning strategy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Re-intubation rate in each group.

  30 days

• Mortality rate in each group

  30 days

• Duration spent on NIV

  An average of 30 days

• Length of ICU stay

  An average of 30 days

• Degree of patient's comfort

  An average of 30 days

Study Arms (2)

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.

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.

Device: Extubation to NIV

Interventions

Extubation to NIV DEVICE

Weaning using NIV immediately after extubation with the mentioned parameters

Also known as: NIV portable device: Res MED(S9 VPAPTM ST)

I) Extubation to NIV (S/T mode); II) Extubation to NIV (iVAPS) mode

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients in acute exacerbation of COPD who are mechanically ventilated will be included in this study.

You may not qualify if:

• Age \< 18 years or \>75 years.
• Other chest diseases (pneumonia, bronchiectasis, pulmonary embolism, pulmonary fibrosis…).
• Tracheostomized patients.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut University Hospital

Asyut, Assiut University 71515, Egypt

Location

Assiut University Hospital - RICU

Asyut, Egypt

Location

Related Publications (5)

• 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.

  PMID: 19541716 BACKGROUND

• 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.

  PMID: 24324020 BACKGROUND

• Talwar D, Dogra V. Weaning from mechanical ventilation in chronic obstructive pulmonary disease: Keys to success. J Assoc Chest Physicians 2016;4:43-9.

  BACKGROUND

• 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.

  PMID: 24661390 BACKGROUND

• 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.

  PMID: 17323049 BACKGROUND

Study Officials

• Suzan S Sayed, MD

  Assiut University

  STUDY CHAIR

• Aliaë A. Mohamed-Hussein, MD

  Assiut University

  STUDY DIRECTOR

• Doaa M Magdy, MD

  Assiut University

  STUDY DIRECTOR

• Sarah M Hamza, MSc

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 19, 2017
• Study Start: October 25, 2017
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)