Clinical trial NCT04362787: High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure
Official title: High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Hypercapnic Respiratory Failure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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 .

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.

Primary outcomes:
measure: High pressure non invasive ventilation in acute hypercapnic respiratory failure
timeFrame: Patients will assessed after 2 hours from increasing pressure
measure: High pressure non invasive ventilation in acute hypercapnic respiratory failure
timeFrame: Patients will assessed after 2 hours from increasing pressure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor of chest diseases Faculty of medicine Assiut university
name: Khaled Hu Ahmed
role: STUDY_DIRECTOR
References: