COPD ExacerbationNCT03296215
Pattern of Admitted Cases in Respiratory Intensive Care Unit at Assiut University Hospitals
An observational study of COPD Exacerbation, run by Assiut University.
Trial summary
Human health comprises many different states, ranging from perfect health to critical illness, so medical facilities should be able to provide medical assistance tailored to the patient's degree of disease. Read more about this study
- Who is it for?
- Ages 18 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Observational
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Mar 2020
- 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 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Only patients admitted to repiratory ICU
Who may be able to join
- Patients with the following conditions are candidates for admission to the respiratory Intensive Care Unit. The following conditions include, but are not limited to:
- Acute respiratory failure requiring ventilatory support
- Acute pulmonary embolism with haemodynamic instability
- Massive haemoptysis
- Upper airway obstruction
Who cannot join
- Patients who are generally not appropriate for respiratory ICU admission:
- Irreversible brain damage
- End stage cardiac, respiratory and liver disease with no options for transplant
- Metastatic cancer unresponsive to chemotherapy and/or radiotherapy
- Patients with non-traumatic coma leading to a persistent vegetative state (7,8,9,10)
Trial locations and contacts
No sites are listed yet.
About this study
Human health comprises many different states, ranging from perfect health to critical illness, so medical facilities should be able to provide medical assistance tailored to the patient's degree of disease.
The Intensive Care Unit (ICU) serves as a place for monitoring and care of patients with potentially severe physiologic instability requiring technical and/or artificial life support. The level of care in an ICU is greater than that available on the floor or Intermediate Care Unit.
Read more
Because of the utilization of expensive resources, ICUs should, in general, be reserved for those patients with reversible medical conditions who have a "reasonable prospect of substantial recovery".
About one third of hospital mortality occurs in critically ill patients in the intensive care unit. On the other hand, critically ill patients are responsible for 10 - 20 % of global hospital costs.
It is well accepted that early appropriate referral of patients to an ICU can significantly reduce early and possibly late mortality in the critically ill.At the same time improper selection of patients for ICU who block ICU beds often limits bed availability in ICUs. This in turn adversely affects the dynamics the whole hospital.
The Respiratory Intensive Care Unit (RICU) is an area that provides closed monitoring and intensive treatment for patients with acute or exacerbated respiratory failure caused by a disease that is primarily respiratory.
- Conditions
- COPD Exacerbation
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
To determine different patterns of admission and their Outcome
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patterno of admitted cases in Respiratory Intensive Care Unit at Assiut University Hospitals and Outcome Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of study is determine prognosis of patients admitted in Respiratory Intensive Care Unit at Assiut University Hospitals.
Assessment of Acute Physiology and Health Evaluation II (APHCHE II) score of each admitted case.
Measured: First 24hours of admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionMar 2020 (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 COPD ExacerbationStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Badwy, Assiut University
- Investigators
- Mahmoud Badwy, Resident, Principal investigator, Assiut UniversityYousef Ahmad, Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296215
- Sponsor's protocol ID
- Mahmoud Badwy2017
- Status last verified
- Sep 2017
- First submitted
- 9 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available for primary Outcome
Publications
Kahn JM, Goss CH, Heagerty PJ, Kramer AA, O'Brien CR, Rubenfeld GD. Hospital volume and the outcomes of mechanical ventilation. N Engl J Med. 2006 Jul 6;355(1):41-50. doi: 10.1056/NEJMsa053993.
PubMed 16822995
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Admitted Cases in Respiratory Intensive Care Unit at Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT03296215
- Acronym / sponsor ID
- Mahmoud Badwy2017
- Conditions
- COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 28 Sep 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.
Human health comprises many different states, ranging from perfect health to critical illness, so medical facilities should be able to provide medical assistance tailored to the patient's degree of disease.
The Intensive Care Unit (ICU) serves as a place for monitoring and care of patients with potentially severe physiologic instability requiring technical and/or artificial life support. The level of care in an ICU is greater than that available on the floor or Intermediate Care Unit.
Because of the utilization of expensive resources, ICUs should, in general, be reserved for those patients with reversible medical conditions who have a "reasonable prospect of substantial recovery".
About one third of hospital mortality occurs in critically ill patients in the intensive care unit. On the other hand, critically ill patients are responsible for 10 - 20 % of global hospital costs.
It is well accepted that early appropriate referral of patients to an ICU can significantly reduce early and possibly late mortality in the critically ill.At the same time improper selection of patients for ICU who block ICU beds often limits bed availability in ICUs. This in turn adversely affects the dynamics the whole hospital.
The Respiratory Intensive Care Unit (RICU) is an area that provides closed monitoring and intensive treatment for patients with acute or exacerbated respiratory failure caused by a disease that is primarily respiratory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: ObservationalPatterno of admitted cases in Respiratory Intensive Care Unit at Assiut University Hospitals and Outcome |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients admitted to repiratory ICU
Key inclusion criteria (5 listed)
- Patients with the following conditions are candidates for admission to the respiratory Intensive Care Unit. The following conditions include, but are not limited to:
- Acute respiratory failure requiring ventilatory support
- Acute pulmonary embolism with haemodynamic instability
- Massive haemoptysis
- Upper airway obstruction
Key exclusion criteria (5 listed)
- Irreversible brain damage
- End stage cardiac, respiratory and liver disease with no options for transplant
- Metastatic cancer unresponsive to chemotherapy and/or radiotherapy
- Patients with non-traumatic coma leading to a persistent vegetative state (7,8,9,10)
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 |
|---|---|---|
| ObservationalTo determine different patterns of admission and their Outcome | Other | Observational |
Primary outcome
The purpose of study is determine prognosis of patients admitted in Respiratory Intensive Care Unit at Assiut University Hospitals.
Time frame: First 24hours of admission.
Assessment of Acute Physiology and Health Evaluation II (APHCHE II) score of each admitted case.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Background: PubMed 16822995Kahn JM, Goss CH, Heagerty PJ, Kramer AA, O'Brien CR, Rubenfeld GD. Hospital volume and the outcomes of mechanical ventilation. N Engl J Med. 2006 Jul 6;355(1):41-50. doi: 10.1056/NEJMsa053993.
- Individual participant dataSharing planned: Yes. Individual participant data will be available for primary Outcome
Related trials for COPD Exacerbation
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
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FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation
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Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
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Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
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Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
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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.
Mahmoud Badwy, Resident principal investigator
Assiut University
Yousef Ahmad, Prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, 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 5 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 28 Sep 2017. 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 Mahmoud Badwy, Resident (01016149089, mah55667755@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The purpose of study is determine prognosis of patients admitted in Respiratory Intensive Care Unit at Assiut University Hospitals. (time frame: First 24hours of admission.). 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 NCT03296215, 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 28 Sep 2017.