HypercapniaNCT05948527
Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia
A study testing high flow nasal canula in people with Hypercapnia, run by Mansoura University at 1 site in Egypt.
Trial summary
Evaluate safety and efficacy of application ( high flow nasal canula) in cases with mild hypercapnia, included 30 patients who were hospitalized in Mansoura University chest department with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disease categories (Chronic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercapnia
- What is being tested?
- high flow nasal canula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jul 2023
- Phase
- Interventional
- 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
Who may be able to join
- patients with mild Hypercapnia
Who cannot join
- Excluded cases had age less than 18 years or pediatric group .
- patients with their mental state altered, confused, comatose, severe agitation or non cooperative
- Cases with moderate or severe Hypercapnia
- cases in need for immediate invasive mechanical ventilation
- cases with respiratory rate more than 35 breath per minute.
- cases with Respiratory exhaustion , fatigue , excess use of respiratory accessory muscles
Show all 10Show fewer
- Shock , hemodynamic instability, post arrest cases,
- cases with facial trauma or severe nasal deformity,
- Patients with sleep breathing disorders or upper airway obstruction
- patients with history of home ventilation prior admission
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
Evaluate safety and efficacy of application ( high flow nasal canula) in cases with mild hypercapnia, included 30 patients who were hospitalized in Mansoura University chest department with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disease categories (Chronic obstructive pulmonary disease acute exacerbation, pneumonia, Interstitial lung diseases, etc).
- Conditions
- Hypercapnia
- Being tested
- high flow nasal canula
- Keywords
- hypercapnia, high flow nasal canula
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal canulaDevice
administration of high flow nasal canula at initial flow 35 liters per minute and Fio2 (fraction of inspired oxygen of 50%) with titration to reach oxygen saturation of 88-92%.
| Study group | Role | What they receive |
|---|---|---|
| with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) | Experimental | with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disorders Receives: Device: high flow nasal canula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Blood Gases changes
The primary outcome was concerned about changes in Arterial Blood Gases in first 24 h after admission and the same changes 48 h after admission.
Measured: 48 hours
Secondary outcomes (1)
Number of participants in need for ventilation
Secondary outcome was concerned about need to non invasive mechanical ventilation or invasive mechanical ventilation.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Jan 2023
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercapniaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948527
- Sponsor's protocol ID
- R.22.12.1978.R1.R2
- Status last verified
- Jun 2023
- First submitted
- 24 Jun 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: study protocol
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia
- ClinicalTrials.gov ID
- NCT05948527
- Acronym / sponsor ID
- R.22.12.1978.R1.R2
- Conditions
- Hypercapnia
- Keywords
- hypercapnia, high flow nasal canula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 17 Jul 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.
Evaluate safety and efficacy of application ( high flow nasal canula) in cases with mild hypercapnia, included 30 patients who were hospitalized in Mansoura University chest department with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disease categories (Chronic obstructive pulmonary disease acute exacerbation, pneumonia, Interstitial lung diseases, etc).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) | Experimental | Device: high flow nasal canulawith mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disorders |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with mild Hypercapnia
Key exclusion criteria (10 listed)
- Excluded cases had age less than 18 years or pediatric group .
- patients with their mental state altered, confused, comatose, severe agitation or non cooperative
- Cases with moderate or severe Hypercapnia
- cases in need for immediate invasive mechanical ventilation
- cases with respiratory rate more than 35 breath per minute.
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 flow nasal canulaadministration of high flow nasal canula at initial flow 35 liters per minute and Fio2 (fraction of inspired oxygen of 50%) with titration to reach oxygen saturation of 88-92%. | Device | with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) |
Primary outcome
Arterial Blood Gases changes
Time frame: 48 hours
The primary outcome was concerned about changes in Arterial Blood Gases in first 24 h after admission and the same changes 48 h after admission.
1 secondary outcome
Number of participants in need for ventilation
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: Undecided. study protocol
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal canula in people with Hypercapnia, run by Mansoura 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 10 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: finished, as of the sponsor's last update on 17 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Blood Gases changes (time frame: 48 hours). 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 17 Jul 2023.