Chest--DiseasesNCT03169452
Clinical Application and Outcome of Non-invasive Ventilation in Different Chest Diseases
An observational study of Chest--Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
Noninvasive ventilation is increasingly used method of respiratory management in both the emergency room and critical care. Noninvasive ventilation delivers mechanically assisted breaths without the placement of an artificial airway and has become an important mechanism of ventilator support inside and outside the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest--Diseases
- What is being tested?
- Non-invasive mechanical ventilator
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who admitted to the Respiratory intensive care unit and the attending team conducted him to Non invasive ventilation
Who may be able to join
- obstructive sleep apnea syndrome
- acute exacerbation Chronic obstructive pulmonary disease
- pneumonia
- interstitial lung diseases
Who cannot join
- Patients refuse Non invasive ventilation
- Patients with absolute indication for Mechanical ventilator (in respiratory arrest or unstable cardiorespiratory status, trauma or burns involving the face, or gastric surgery, reduced consciousness, Pneumothorax
- Patients with contraindication to Non invasive ventilation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut
Ahmed Abbas, MD, 00201003385183
About this study
Noninvasive ventilation is increasingly used method of respiratory management in both the emergency room and critical care. Noninvasive ventilation delivers mechanically assisted breaths without the placement of an artificial airway and has become an important mechanism of ventilator support inside and outside the intensive care unit.
Noninvasive ventilation is further subdivided into negative pressure ventilation which is the iron lung, first used in 1928 and the Hayek oscillator, is a more recently designed to provide negative pressure during inspiration and positive pressure during expiration. Noninvasive positive pressure ventilation can be used as continuous positive airway pressure or bi-level positive airway pressure.
- Conditions
- Chest--Diseases
- Being tested
- Non-invasive mechanical ventilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive mechanical ventilatorDevice
Also called continuous positive airway pressure
mechanical assisted breaths without the placement of an artificial way
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients need mechanical ventilation
the number of patients without improvement on non-invasive ventilator and require transfer to mechanical ventilator
Measured: 1-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Jun 2017
- Primary completionAug 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest--DiseasesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169452
- Sponsor's protocol ID
- NIV
- Status last verified
- Jun 2018
- First submitted
- 25 May 2017
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application and Outcome of Non-invasive Ventilation in Different Chest Diseases
- ClinicalTrials.gov ID
- NCT03169452
- Acronym / sponsor ID
- NIV
- Conditions
- Chest--Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 30 May 2017 (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.
Noninvasive ventilation is increasingly used method of respiratory management in both the emergency room and critical care. Noninvasive ventilation delivers mechanically assisted breaths without the placement of an artificial airway and has become an important mechanism of ventilator support inside and outside the intensive care unit.
Noninvasive ventilation is further subdivided into negative pressure ventilation which is the iron lung, first used in 1928 and the Hayek oscillator, is a more recently designed to provide negative pressure during inspiration and positive pressure during expiration. Noninvasive positive pressure ventilation can be used as continuous positive airway pressure or bi-level positive airway pressure.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who admitted to the Respiratory intensive care unit and the attending team conducted him to Non invasive ventilation
Key inclusion criteria (4 listed)
- obstructive sleep apnea syndrome
- acute exacerbation Chronic obstructive pulmonary disease
- pneumonia
- interstitial lung diseases
Key exclusion criteria (3 listed)
- Patients refuse Non invasive ventilation
- Patients with absolute indication for Mechanical ventilator (in respiratory arrest or unstable cardiorespiratory status, trauma or burns involving the face, or gastric surgery, reduced consciousness, Pneumothorax
- Patients with contraindication to Non invasive ventilation
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 |
|---|---|---|
| Non-invasive mechanical ventilatorAlso: continuous positive airway pressuremechanical assisted breaths without the placement of an artificial way | Device | – |
Primary outcome
percentage of patients need mechanical ventilation
Time frame: 1-48 hours
the number of patients without improvement on non-invasive ventilator and require transfer to mechanical ventilator
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- 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. This study is not recruiting at the moment.
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 Chest--Diseases, 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 4 inclusion and 3 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 3 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sahar Mohamed, MBBCh (00201069916415, saharmuhammad25@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients need mechanical ventilation (time frame: 1-48 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 3 Jul 2018.