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

January 11, 2021 updated by: Sarah Mohammed Hashem Hamza Ahmed, Assiut University

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

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, Assiut university 71515
        • Assiut university hospital
      • Assiut, Egypt
        • Assiut University Hospital - RICU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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
Weaning using NIV immediately after extubation with the mentioned parameters
Other Names:
  • NIV portable device: Res MED(S9 VPAPTM ST)
Experimental: II) Extubation to NIV (iVAPS) mode

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
Weaning using NIV immediately after extubation with the mentioned parameters
Other Names:
  • NIV portable device: Res MED(S9 VPAPTM ST)

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

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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