Acute Hypercapnic Respiratory FailureNCT04362787
High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure
An observational study of Acute Hypercapnic Respiratory Failure, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Hypercapnic Respiratory Failure
- What is being tested?
- High pressure non invasive ventilation in acute hypercapnic respiratory failure
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who failed on low pressure NIV will be shifted to high pressure NIV with any of these
Who may be able to join
- 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%.
Who cannot join
- 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.
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- Cardiac or respiratory arrest.
- PH<7.25.
- Arterial oxygen tension /fraction of inspired oxygen (PaO2 / FiO2) <150mmHg.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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:
- Still in a number of patients with conventional low pressure NIV, PaCO2, and pH worsen with subsequent deterioration and need for invasive ventilation.
- 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.
- Also abnormally high level PaCO2 may have a negative impact on vital organs.
- 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 .
- Conditions
- Acute Hypercapnic Respiratory Failure
- Being tested
- High pressure non invasive ventilation in acute hypercapnic respiratory failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High pressure non invasive ventilation in acute hypercapnic respiratory failureDevice
Usage of High pressure non invasive ventilation in acute hypercapnic respiratory failure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: High pressure non invasive ventilation in acute hypercapnic respiratory failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Patients will assessed after 2 hours from increasing pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Eissa Helmy Abdelhafeez, Assiut University
- Investigators
- Khaled Hu Ahmed, Study director, Professor of chest diseases Faculty of medicine Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362787
- Sponsor's protocol ID
- High pressure
- Status last verified
- Jul 2020
- First submitted
- 23 Apr 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT04362787
- Acronym / sponsor ID
- High pressure
- Conditions
- Acute Hypercapnic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Still in a number of patients with conventional low pressure NIV, PaCO2, and pH worsen with subsequent deterioration and need for invasive ventilation.
- 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.
- Also abnormally high level PaCO2 may have a negative impact on vital organs.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High pressure _ low pressure non-invasive ventilation | – | Device: High pressure non invasive ventilation in acute hypercapnic respiratory failureIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who failed on low pressure NIV will be shifted to high pressure NIV with any of these
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High pressure non invasive ventilation in acute hypercapnic respiratory failureUsage of High pressure non invasive ventilation in acute hypercapnic respiratory failure | Device | High pressure _ low pressure non-invasive ventilation |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled Hu Ahmed study director
Professor of chest diseases Faculty of medicine Assiut university
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hypercapnic Respiratory Failure, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Ei Abdelhafeez, Master (010911477791 ext. 01065854758, mahaeissa2018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High pressure non invasive ventilation in acute hypercapnic respiratory failure (time frame: Patients will assessed after 2 hours from increasing pressure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020; AzTrials last refreshed its copy on 1 Nov 2026.