High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure

NCT04362787 | Unknown

• 1 other identifier: High pressure
• Study Type: observational
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

High pressure non invasive ventilation in acute hypercapnic respiratory failure DEVICE

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

High pressure _ low pressure non-invasive ventilation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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:
• PH \<7.30 or less than admission level.
• RR \> 35b/m or more than admission level.
• SpO2 \< 88%.

You may not qualify if:

• Age \<18 years.
• Excessive amount of respiratory secretions or weak cough.
• Upper airway obstruction.
• Recent oral, facial or cranial trauma or surgery.
• Sever abdominal distension.
• Active upper gastrointestinal bleeding.
• Cardiac or respiratory arrest.
• PH\<7.25.
• Arterial oxygen tension /fraction of inspired oxygen (PaO2 / FiO2) \<150mmHg.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Khaled Hu Ahmed

  Professor of chest diseases Faculty of medicine Assiut university

  STUDY DIRECTOR

Central Study Contacts

Maha Ei Abdelhafeez, Master

CONTACT

010911477791; mahaeissa2018@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: August 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: July 13, 2020

Record last verified: 2020-07