BronchiectasisNCT05741697
HFNC in Management of Bronchiectasis Exacerbation
An observational study of Bronchiectasis, run by Assiut University at 1 site in Egypt.
Trial summary
Patients with Bronchiectasis experience exacerbations with hypercapnic respiratory failure associated with an increased respiratory workload that may require intensive care unit (ICU) admission due to the inability of the respiratory muscles to compensate for increased demand. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- bi-level ventillation
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Adult, Older adult
Study population: Patients will be eligible for enrolment if diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU), requiring ventilator support without invasive mechanical ventilation.
Who may be able to join
- Patients will be eligible for enrolment if diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU), requiring ventilator support without invasive mechanical ventilation.
Who cannot join
- Age: less than 18 years. Patients with post-arrest encephalopathy. Patient with the previous tracheotomy. Patients who received invasive ventilatory support. Patients with end-organ failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University-Faculty of medicine
Asyut, 71515
ahmad shaddad, MD, +201111171930, shaddad_ahmad@yahoo.com
About this study
Official title: High Flow Nasal Cannula Versus Non-invasive Ventilation in Managing Acute Exacerbation of Bronchiectasis Patients
Patients with Bronchiectasis experience exacerbations with hypercapnic respiratory failure associated with an increased respiratory workload that may require intensive care unit (ICU) admission due to the inability of the respiratory muscles to compensate for increased demand. These exacerbations are frequently treated with noninvasive ventilation (NIV).
Read the detailed description
NIV has been shown to unload the respiratory muscles, increase alveolar ventilation and gas exchange and reverse the rapid and shallow breathing pattern commonly adopted by bronchiectasis patients with advanced lung disease.
NIV is a cornerstone therapy for hypercapnic acute respiratory failure. Still, there is also an increasing interest in high-flow nasal cannula (HFNC) as a potential alternative treatment in this indication. HFNC delivers an actively heated and fully humidified gas mixture with flow rates up to 60 L/min and adjustable FiO2 from 21 to 100%. The high flow rates generate small amounts of positive end-expiratory pressure (PEEP) that may help counterbalance the effects of intrinsic PEEP (PEEPi) on the work of breathing and might act by washing out of the physiological dead space. Furthermore, it could help to facilitate secretion clearance from the humidified gas.
Studies have demonstrated the benefits of HFNC in acute hypoxemic respiratory failure, after cardiothoracic surgery, and in preventing post-extubation failure among unselected cohorts of critically ill patients during weaning from invasive mechanical ventilation.
However, the current evidence of using HFNC in patients with hypercapnic acute respiratory failure is limited. We aime to spotlight this research area.
- Conditions
- Bronchiectasis
- Being tested
- bi-level ventillation
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bi-level ventillationDrug
Also called HFNC
non-invasive mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Patient need NIV ventillation | Patients will be eligible for enrolment if they are diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU); requiring ventilator support without invasive mechanical ventilation and will need NIV Receives: Drug: bi-level ventillation | |
| patient need HFNC | Patients will be eligible for enrolment if they are diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU); requiring ventilator support without invasive mechanical ventilation and will need HFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of efficacy and patient compliance of high flow nasal canula system in comparison to Noninvasive mechanical ventilation in management of acute exacerbation of Bronchiectasis
The duration of ICU admission days and the patient compliance to both devices will be compared.
Measured: March 2023 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Mar 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- WGEKHALEEL, AARMHUSSIEN
- Responsible party
- Principal investigator, Ahmad Shaddad, Assiut University
- Investigators
- Ahmad M. Shaddad, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741697
- Sponsor's protocol ID
- 2627378373
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Versus Non-invasive Ventilation in Managing Acute Exacerbation of Bronchiectasis Patients
- ClinicalTrials.gov ID
- NCT05741697
- Acronym / sponsor ID
- 2627378373
- Conditions
- Bronchiectasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- WGEKHALEEL, AARMHUSSIEN
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 Feb 2023 (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.
Patients with Bronchiectasis experience exacerbations with hypercapnic respiratory failure associated with an increased respiratory workload that may require intensive care unit (ICU) admission due to the inability of the respiratory muscles to compensate for increased demand. These exacerbations are frequently treated with noninvasive ventilation (NIV).
Detailed description
NIV has been shown to unload the respiratory muscles, increase alveolar ventilation and gas exchange and reverse the rapid and shallow breathing pattern commonly adopted by bronchiectasis patients with advanced lung disease.
NIV is a cornerstone therapy for hypercapnic acute respiratory failure. Still, there is also an increasing interest in high-flow nasal cannula (HFNC) as a potential alternative treatment in this indication. HFNC delivers an actively heated and fully humidified gas mixture with flow rates up to 60 L/min and adjustable FiO2 from 21 to 100%. The high flow rates generate small amounts of positive end-expiratory pressure (PEEP) that may help counterbalance the effects of intrinsic PEEP (PEEPi) on the work of breathing and might act by washing out of the physiological dead space. Furthermore, it could help to facilitate secretion clearance from the humidified gas.
Studies have demonstrated the benefits of HFNC in acute hypoxemic respiratory failure, after cardiothoracic surgery, and in preventing post-extubation failure among unselected cohorts of critically ill patients during weaning from invasive mechanical ventilation.
However, the current evidence of using HFNC in patients with hypercapnic acute respiratory failure is limited. We aime to spotlight this research area.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient need NIV ventillation | – | Drug: bi-level ventillationPatients will be eligible for enrolment if they are diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU); requiring ventilator support without invasive mechanical ventilation and will need NIV |
| patient need HFNC | – | –Patients will be eligible for enrolment if they are diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU); requiring ventilator support without invasive mechanical ventilation and will need HFNC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be eligible for enrolment if diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU), requiring ventilator support without invasive mechanical ventilation.
Key inclusion criteria (1 listed)
- Patients will be eligible for enrolment if diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU), requiring ventilator support without invasive mechanical ventilation.
Key exclusion criteria (1 listed)
- Age: less than 18 years. Patients with post-arrest encephalopathy. Patient with the previous tracheotomy. Patients who received invasive ventilatory support. Patients with end-organ failure.
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 |
|---|---|---|
| bi-level ventillationAlso: HFNCnon-invasive mechanical ventilation | Drug | Patient need NIV ventillation |
Primary outcome
Assessment of efficacy and patient compliance of high flow nasal canula system in comparison to Noninvasive mechanical ventilation in management of acute exacerbation of Bronchiectasis
Time frame: March 2023 to December 2023
The duration of ICU admission days and the patient compliance to both devices will be compared.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Ahmad M. Shaddad principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmad shaddad, MD (+201111171930, shaddad_ahmad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of efficacy and patient compliance of high flow nasal canula system in comparison to Noninvasive mechanical ventilation in management of acute exacerbation of Bronchiectasis (time frame: March 2023 to December 2023). 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 24 Sep 2026.