Effects of Obesity on COPD Mechanically Ventilated PatientsNCT06048549
The Effect of Obesity in COPD Mechanically Ventilated Patients
An observational study of Effects of Obesity on COPD Mechanically Ventilated Patients, run by Assiut University.
Trial summary
Study the relationship between the body mass index and duration of mechanical ventilation \& complications in mechanically ventilated COPD patients. Study the effect of obesity on mortality rate of COPD mechanically ventilated patients. Determine prevalence of obesity in mechanically ventilated COPD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Effects of Obesity on COPD Mechanically Ventilated Patients
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients of both genders more than 18 years old admitted at RICU, diagnosed COPD and need mechanical ventilation from August 2023 to August 2024.
Who may be able to join
- Adult patients of both genders more than 18 years old admitted at RICU, diagnosed COPD and need mechanical ventilation from August 2023 to August 2024.
Who cannot join
- patients less than 18 years old. patients who refused to participate in the research. patients with missing data.
About this study
Official title: Effect Of Obesity on The Outcome Of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
Study the relationship between the body mass index and duration of mechanical ventilation \& complications in mechanically ventilated COPD patients.
Study the effect of obesity on mortality rate of COPD mechanically ventilated patients.
Determine prevalence of obesity in mechanically ventilated COPD patients.
Read the detailed description
Obesity has become a global epidemic with prevalence rising both in developed and developing countries. The percentage of patients with obesity in the intensive care unit (ICU) can be expected to increase concomitantly or even more since obesity increases the risk for a more severe disease course with more need for ICU admission and mechanical ventilation .
Obesity, especially abdominal obesity (android fat distribution) and severe obesity, results in altered respiratory anatomy and physiology and, therefore, complicated airway management and adapted ventilator settings during mechanical ventilation. Obesity appears to be associated with an increased risk of acute respiratory distress syndrome (ARDS) and infection, mainly pneumonia probably related to an imbalanced production of adipokines. In ventilated patients, obesity increases ICU length of stay and the duration of mechanical ventilation .
Obesity is relatively common among individuals with COPD, corresponding to 20%-35% of patients with COPD. Increasing evidence suggests that obesity is a risk factor for impaired quality of life, exercise intolerance, and suboptimal disease control in COPD .
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the effect of obesity on morbidity and mortality rate of COPD mechanically ventilated patients.
Study the relationship between the body mass index and duration of mechanical ventilation \& complications in mechanically ventilated COPD patients.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Obesity on COPD Mechanically Ventilated PatientsStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Gamal Abd Elhamied, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048549
- Sponsor's protocol ID
- Obesity COPD Patients
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Obesity on The Outcome Of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT06048549
- Acronym / sponsor ID
- Obesity COPD Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Sep 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.
Study the relationship between the body mass index and duration of mechanical ventilation \& complications in mechanically ventilated COPD patients.
Study the effect of obesity on mortality rate of COPD mechanically ventilated patients.
Determine prevalence of obesity in mechanically ventilated COPD patients.
Detailed description
Obesity has become a global epidemic with prevalence rising both in developed and developing countries. The percentage of patients with obesity in the intensive care unit (ICU) can be expected to increase concomitantly or even more since obesity increases the risk for a more severe disease course with more need for ICU admission and mechanical ventilation .
Obesity, especially abdominal obesity (android fat distribution) and severe obesity, results in altered respiratory anatomy and physiology and, therefore, complicated airway management and adapted ventilator settings during mechanical ventilation. Obesity appears to be associated with an increased risk of acute respiratory distress syndrome (ARDS) and infection, mainly pneumonia probably related to an imbalanced production of adipokines. In ventilated patients, obesity increases ICU length of stay and the duration of mechanical ventilation .
Obesity is relatively common among individuals with COPD, corresponding to 20%-35% of patients with COPD. Increasing evidence suggests that obesity is a risk factor for impaired quality of life, exercise intolerance, and suboptimal disease control in COPD .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of both genders more than 18 years old admitted at RICU, diagnosed COPD and need mechanical ventilation from August 2023 to August 2024.
Key inclusion criteria (1 listed)
- Adult patients of both genders more than 18 years old admitted at RICU, diagnosed COPD and need mechanical ventilation from August 2023 to August 2024.
Key exclusion criteria (1 listed)
- patients less than 18 years old. patients who refused to participate in the research. patients with missing data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study the effect of obesity on morbidity and mortality rate of COPD mechanically ventilated patients.
Time frame: one year
Study the relationship between the body mass index and duration of mechanical ventilation \& complications in mechanically ventilated COPD patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Effects of Obesity on COPD Mechanically Ventilated Patients, 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 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
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?
Study the effect of obesity on morbidity and mortality rate of COPD mechanically ventilated patients. (time frame: one year). 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 21 Sep 2023.