Chronic Obstructive Pulmonary Disease(COPD)NCT04735497
Ventilator Asynchrony as a Predictor of Weaning Failure
An observational study of Chronic Obstructive Pulmonary Disease(COPD), run by Reham Mohammed Elmorshedy at 1 site in Egypt.
Trial summary
Patient ventilator asynchrony is a common problem in mechanically ventilated patients .It is associated with adverse effects including increased work of breathing, patient discomfort, increased need for sedation, prolonged mechanical ventilation , weaning difficulties and weaning failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease(COPD)
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2018to 20 Dec 2019
- 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 COPD patients who were diagnosed after history ,physical examination ,radiology and pulmonary function tests and required mechanical ventilation.
Who may be able to join
- All COPD patients who were diagnosed after history ,physical examination radiology and pulmonary function tests and required mechanical ventilation.
Who cannot join
- Age < 18 years
- Tracheostomy
- Failure to trigger breaths even in cases of receiving neuromuscular blocking agents.
- Encephalopathy which is not caused by hypercapnia or hypoxemia either post arrest or due to cerebrovascular stroke
- Patients with unplanned weaning
- COPD patients where intubation not related to exacerbation e.g. acute pulmonary edema.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Ventilator Asynchrony as a Predictor of Weaning Failure in Mechanically Ventilated COPD Patients
Patient ventilator asynchrony is a common problem in mechanically ventilated patients .It is associated with adverse effects including increased work of breathing, patient discomfort, increased need for sedation, prolonged mechanical ventilation , weaning difficulties and weaning failure. 100 mechanically ventilated COPD patients were enrolled in this prospective study .Detection of patient ventilator asynchrony was done on 30-minute sessions at 12, 24, 36, and 48 hours following intubation by visual assessment of pressure, flow and volume graphs on ventilator .
Read the detailed description
Patient-ventilator asynchrony is defined as a lack of organization between the patient and ventilator timing of both inspiration and expiration . It is a commonly reported problem during mechanical ventilation. Thille et al. found that 24% of patients developed asynchrony in at least ten percent of their breaths, moreover they stated that the most frequent asynchronies was each of ineffective triggering and double triggering . Eighty percent of chronic obstructive pulmonary disease (COPD) patients experienced ineffective triggering, where it is considered the most frequent asynchrony in this group of patients. Asynchrony between Patient and ventilator also leads to prolonged duration of invasive ventilation, and increase possibility of weaning failure.
Both spread and intensity of asynchrony during the early phase of weaning in COPD patients has never satisfactorily described. The aim of the current study was to describe the patient-ventilator asynchrony and its impact on weaning outcome in mechanically ventilated COPD patients.
- Keywords
- mechanically ventilated, weaning failure, COPD, asynchrony
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Failed Weaning | Patients who failed to be liberated from mechanical ventillation | |
| Successful Weaning | Patients who were liberated from mechanical ventillation and needed no respiratory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study effect of different types of ventilator asynchrony on weaning in mechanically ventilated COPD patients
Detection of patient ventilator asynchrony was done on 30-minute sessions following intubation by visual assessment of pressure, flow
and volume graphs on ventilator .Repeated measures are done from the begining of mechanical ventilation and type of asynchronies including ineffective trigger double trigger, auto trigger , delayed cycle, early cycle and flow asynchrony. were recorded.
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 posted3 Feb 2021
- Study start15 Feb 2018
- Primary completion15 Aug 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease(COPD)Studies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reham Mohammed Elmorshedy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reham Mohammed Elmorshedy, Assiut University
- Investigators
- Samiaa Sadek, Ass.Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735497
- Sponsor's protocol ID
- Ventilator Asynchrony
- Status last verified
- Feb 2021
- First submitted
- 11 Jan 2021
- Last updated
- 10 Feb 2021
- 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 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Ventilator Asynchrony as a Predictor of Weaning Failure in Mechanically Ventilated COPD Patients
- ClinicalTrials.gov ID
- NCT04735497
- Acronym / sponsor ID
- Ventilator Asynchrony
- Keywords
- mechanically ventilated, weaning failure, COPD, asynchrony
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Reham Mohammed ElmorshedyUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 3 Feb 2021 (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.
Patient ventilator asynchrony is a common problem in mechanically ventilated patients .It is associated with adverse effects including increased work of breathing, patient discomfort, increased need for sedation, prolonged mechanical ventilation , weaning difficulties and weaning failure. 100 mechanically ventilated COPD patients were enrolled in this prospective study .Detection of patient ventilator asynchrony was done on 30-minute sessions at 12, 24, 36, and 48 hours following intubation by visual assessment of pressure, flow and volume graphs on ventilator .
Detailed description
Patient-ventilator asynchrony is defined as a lack of organization between the patient and ventilator timing of both inspiration and expiration . It is a commonly reported problem during mechanical ventilation. Thille et al. found that 24% of patients developed asynchrony in at least ten percent of their breaths, moreover they stated that the most frequent asynchronies was each of ineffective triggering and double triggering . Eighty percent of chronic obstructive pulmonary disease (COPD) patients experienced ineffective triggering, where it is considered the most frequent asynchrony in this group of patients. Asynchrony between Patient and ventilator also leads to prolonged duration of invasive ventilation, and increase possibility of weaning failure.
Both spread and intensity of asynchrony during the early phase of weaning in COPD patients has never satisfactorily described. The aim of the current study was to describe the patient-ventilator asynchrony and its impact on weaning outcome in mechanically ventilated COPD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Failed Weaning | – | –Patients who failed to be liberated from mechanical ventillation |
| Successful Weaning | – | –Patients who were liberated from mechanical ventillation and needed no respiratory support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All COPD patients who were diagnosed after history ,physical examination ,radiology and pulmonary function tests and required mechanical ventilation.
Key inclusion criteria (1 listed)
- All COPD patients who were diagnosed after history ,physical examination radiology and pulmonary function tests and required mechanical ventilation.
Key exclusion criteria (7 listed)
- Age < 18 years
- Tracheostomy
- Failure to trigger breaths even in cases of receiving neuromuscular blocking agents.
- Encephalopathy which is not caused by hypercapnia or hypoxemia either post arrest or due to cerebrovascular stroke
- Patients with unplanned weaning
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
To study effect of different types of ventilator asynchrony on weaning in mechanically ventilated COPD patients
Time frame: One year
Detection of patient ventilator asynchrony was done on 30-minute sessions following intubation by visual assessment of pressure, flow and volume graphs on ventilator .Repeated measures are done from the begining of mechanical ventilation and type of asynchronies including ineffective trigger double trigger, auto trigger , delayed cycle, early cycle and flow asynchrony. were recorded.
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 10 Feb 2021.
- 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.
Samiaa Sadek, Ass.Lecturer principal investigator
Assiut University
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 Chronic Obstructive Pulmonary Disease(COPD), run by Reham Mohammed Elmorshedy 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 7 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 10 Feb 2021. 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?
To study effect of different types of ventilator asynchrony on weaning in mechanically ventilated COPD 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 10 Feb 2021.