High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure

Acute Hypercapnic Respiratory Failure Clinical Trial

Official title:

High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04362787
• Other study ID #: High pressure
• Status: Not yet recruiting
• Start date: August 1, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: Maha Ei Abdelhafeez, Master
• Phone: 010911477791
• Email: mahaeissa2018[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Hypercapnic Respiratory Failure
• Hypercapnia
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High pressure non invasive ventilation in acute hypercapnic respiratory failure	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.	Patients will assessed after 2 hours from increasing pressure
Primary	High pressure non invasive ventilation in acute hypercapnic respiratory failure	Effect of high pressure NIV on length of hospital stay , need for invasive mechanical ventilation, mortality.	Patients will assessed after 2 hours from increasing pressure