Pulmonary Disease, Chronic ObstructiveNCT03230617
Dynamic Hyperinflation In Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
An observational study of Pulmonary Disease, Chronic Obstructive, run by Assiut University at 1 site in Egypt.
Trial summary
Chronic obstructive pulmonary disease is a common respiratory condition that is characterized by inflammation of the large and small peripheral airways , the alveoli and adjacent capillary networks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Mechanical ventilator
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patient who diagnosed as chronic obstructive pulmonary disease admitted to the respiratory intensive care unit, chest department, Assiut university hospital, who are mechanically ventilated.
Who may be able to join
- patient with acute exacerbation of Chronic obstructive pulmonary disease and respiratory failure who are intubated and mechanically ventilated.
Who cannot join
- patient with neuromuscular diseases.
- patient with pulmonary vascular diseases e.g pulmonary embolism.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University
Asyut
Nisreen Marghany Taha, MD, 01019293548, Nisreen.new@Gmail.com
About this study
Official title: Evaluation Of Dynamic Hyperinflation In Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
Chronic obstructive pulmonary disease is a common respiratory condition that is characterized by inflammation of the large and small peripheral airways , the alveoli and adjacent capillary networks. Severe airflow obstruction that imposes a significant load on the respiratory system is a major manifestation of Chronic obstructive pulmonary disease. The reduced expiratory airflow also causes air trapping at the end of expiration , producing alveolar pressure that are higher than atmospheric pressure before the next breath. This condition is intrinsic positive end-expiratory pressure .
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Mechanical ventilator
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilatorDevice
Mechanical ventilation, in the healthcare setting or home, helps patients breathe by assisting the inhalation of oxygen into the lungs and the exhalation of carbon dioxide. Depending on the patient's condition, mechanical ventilation can help support or completely control breathing.
| Study group | Role | What they receive |
|---|---|---|
| Intrinsic positive end expiratory pressure > 5 | chronic obstructive pulmonary disease patient with intrinsic positive end expiratory pressure more than5 Receives: Device: Mechanical ventilator | |
| Auto positive end expiratory pressure < 5 | chronic obstructive pulmonary disease patient with intrinsic positive end expiratory pressure less than5 Receives: Device: Mechanical ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of mechanical ventilation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisreen Mtk, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230617
- Sponsor's protocol ID
- EDHMVCP
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reddy VG. Auto-PEEP: how to detect and how to prevent--a review. Middle East J Anaesthesiol. 2005 Jun;18(2):293-312.
PubMed 16438005
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Dynamic Hyperinflation In Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT03230617
- Acronym / sponsor ID
- EDHMVCP
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 26 Jul 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.
Chronic obstructive pulmonary disease is a common respiratory condition that is characterized by inflammation of the large and small peripheral airways , the alveoli and adjacent capillary networks. Severe airflow obstruction that imposes a significant load on the respiratory system is a major manifestation of Chronic obstructive pulmonary disease. The reduced expiratory airflow also causes air trapping at the end of expiration , producing alveolar pressure that are higher than atmospheric pressure before the next breath. This condition is intrinsic positive end-expiratory pressure .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrinsic positive end expiratory pressure > 5 | – | Device: Mechanical ventilatorchronic obstructive pulmonary disease patient with intrinsic positive end expiratory pressure more than5 |
| Auto positive end expiratory pressure < 5 | – | Device: Mechanical ventilatorchronic obstructive pulmonary disease patient with intrinsic positive end expiratory pressure less than5 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient who diagnosed as chronic obstructive pulmonary disease admitted to the respiratory intensive care unit, chest department, Assiut university hospital, who are mechanically ventilated.
Key inclusion criteria (1 listed)
- patient with acute exacerbation of Chronic obstructive pulmonary disease and respiratory failure who are intubated and mechanically ventilated.
Key exclusion criteria (2 listed)
- patient with neuromuscular diseases.
- patient with pulmonary vascular diseases e.g pulmonary embolism.
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 |
|---|---|---|
| Mechanical ventilatorMechanical ventilation, in the healthcare setting or home, helps patients breathe by assisting the inhalation of oxygen into the lungs and the exhalation of carbon dioxide. Depending on the patient's condition, mechanical ventilation can help support or completely control breathing. | Device | Auto positive end expiratory pressure < 5, Intrinsic positive end expiratory pressure > 5 |
Primary outcome
The duration of mechanical ventilation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Background: PubMed 16438005Reddy VG. Auto-PEEP: how to detect and how to prevent--a review. Middle East J Anaesthesiol. 2005 Jun;18(2):293-312.
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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 Pulmonary Disease, Chronic Obstructive, 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 2 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 27 Jul 2017. 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 Suzan Salama, MSc (0101423616, Suzansalama61@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of mechanical ventilation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03230617, which also lists 1 linked publication.
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 27 Jul 2017.