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High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure

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ClinicalTrials.gov Identifier: NCT04362787
Recruitment Status : Not yet recruiting
First Posted : April 27, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Maha Eissa Helmy Abdelhafeez, Assiut University

Tracking Information
First Submitted Date April 23, 2020
First Posted Date April 27, 2020
Last Update Posted Date July 13, 2020
Estimated Study Start Date August 1, 2020
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2020)
  • High pressure non invasive ventilation in acute hypercapnic respiratory failure [ Time Frame: Patients will assessed after 2 hours from increasing pressure ]
    To study the efficacy of safety of high pressure NIV in acute hypercapnic respiratory failure due to COPD and obesity hypoventilation syndrome who refractory to low pressure NIV.
  • High pressure non invasive ventilation in acute hypercapnic respiratory failure [ Time Frame: Patients will assessed after 2 hours from increasing pressure ]
    Effect of high pressure NIV on length of hospital stay , need for invasive mechanical ventilation, mortality.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure
Official Title High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure
Brief Summary High pressure NIV is a pressure limited ventilation, stating IPAP pressure at 20 cmH2O and gradually increasing pressure up to 30 cmH2O according to patient tolerance.
Detailed Description

Noninvasive ventilation (NIV): refers to the administration of ventilatory support without using an invasive artificial airway (endotracheal tube or tracheostomy tube). NPPV is well established in the management of acute on chronic hypercapnic respiratory failure secondary to acute exacerbation of COPD (AECOPD), obesity hypoventilation syndrome, and restrictive thoracic disorders.

During the past years NIV was applied by using low pressure inspiratory positive airway pressure (IPAP), which means titrating inspiratory pressure starting at 10 cmH2O and increasing pressure gradually according to patient tolerance maximum up to 20 cm H2O.

There is still about 15% failure rate while using conventional low pressure NIV, this failure rate may be attributed to the following:

  1. Still in a number of patients with conventional low pressure NIV, PaCO2, and pH worsen with subsequent deterioration and need for invasive ventilation.
  2. Despite lowering PaCO2 value with conventional NIV ventilation but it is not normalized so with minimal derangement in clinical condition of the patient it worsens again.
  3. Also abnormally high level PaCO2 may have a negative impact on vital organs.
  4. Low pressure may be associated with patient intolerance , and discontinuation of NIV.

Recently high pressure NIV used aiming to improve outcome of NIV. High pressure NIV is a pressure limited ventilation, stating IPAP pressure at 20 cmH2O and gradually increasing pressure up to 30 cmH2O according to patient tolerance. High pressure NIV is expected to improve alveolar ventilation, decreasing dead space ventilation, and work of breathing, so it can improve the outcome result .

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who failed on low pressure NIV will be shifted to high pressure NIV with any of these
Condition Acute Hypercapnic Respiratory Failure
Intervention Device: High pressure non invasive ventilation in acute hypercapnic respiratory failure
Usage of High pressure non invasive ventilation in acute hypercapnic respiratory failure
Study Groups/Cohorts High pressure _ low pressure non-invasive ventilation

In the high-pressure NIV,52 patients will undergo pressure-limited NPPV at a higher IPAP level. IPAP is initially set at 20 cmH2O and continuously adjusted by increments and decrements of 1-2 cmH2O (up to 30 cmH2O), according to patients' tolerance, to obtain a tidal volume (VT) of 15 mL/kg of IBW.

2- EPAP for patients with COPD will be started at EPAP 5 and will be increased till 7 and for the patients with hypoventilation syndrome will be increased up to EPAP 8.

3-Respiratory rate 10-12 b/min.

Intervention: Device: High pressure non invasive ventilation in acute hypercapnic respiratory failure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 23, 2020)
52
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2023
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

All patients admitted in Assiut University Hospital and Assiut Police Hospital with acute hypercapnic respiratory failure due to COPD and Obesity hypoventilation syndrome (OHS) indicated for conventional NIV.

Patients who failed on low pressure NIV will be shifted to high pressure NIV with any of these conditions:

  1. PH <7.30 or less than admission level.
  2. RR > 35b/m or more than admission level.
  3. SpO2 < 88%.

Exclusion criteria: (4)

  1. Age <18 years.
  2. Excessive amount of respiratory secretions or weak cough.
  3. Upper airway obstruction.
  4. Recent oral, facial or cranial trauma or surgery.
  5. Sever abdominal distension.
  6. Active upper gastrointestinal bleeding.
  7. Cardiac or respiratory arrest.
  8. PH<7.25.
  9. Arterial oxygen tension /fraction of inspired oxygen (PaO2 / FiO2) <150mmHg.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Maha Ei Abdelhafeez, Master 010911477791 ext 01065854758 mahaeissa2018@gmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04362787
Other Study ID Numbers High pressure
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Maha Eissa Helmy Abdelhafeez, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Study Director: Khaled Hu Ahmed Professor of chest diseases Faculty of medicine Assiut university
PRS Account Assiut University
Verification Date July 2020