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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

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.

Condition or disease Intervention/treatment
Acute Hypercapnic Respiratory Failure Device: High pressure non invasive ventilation in acute hypercapnic respiratory failure

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 .

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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Device: High pressure non invasive ventilation in acute hypercapnic respiratory failure
Usage of High pressure non invasive ventilation in acute hypercapnic respiratory failure




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362787


Contacts
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Contact: Maha Ei Abdelhafeez, Master 010911477791 ext 01065854758 mahaeissa2018@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Khaled Hu Ahmed Professor of chest diseases Faculty of medicine Assiut university
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Responsible Party: Maha Eissa Helmy Abdelhafeez, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04362787    
Other Study ID Numbers: High pressure
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory