Accuracy of DE and DTF in Prediction of Extubation SuccessNCT03480828
Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients
An observational study of Accuracy of DE and DTF in Prediction of Extubation Success, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accuracy of DE and DTF in Prediction of Extubation Success
- What is being tested?
- comparaison between DE and DTF in prediction of extubation success
- How many people
- 36 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Apr 2017to 31 Dec 2017
- 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 adult patients who were mechanically ventilated for more than 48 hours and meeting all extubation criteria without a history of neuromuscular disease or severe chronic respiratory failure
Who may be able to join
- patients who were mechanically ventilated for more than 48h and meeting all criteria for extubation
- patients without history of neuromuscular disease, or severe chronic respiratory failure
Who cannot join
- patients who needed reintubation for upper airway obstruction or neurological or hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation.
Read the detailed description
This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation. The investigators compared the median values of DE and DTF in the group of successfully extubated patients and the group of patients who needed reintubation.
Our study compared the utility of DTF and DE to predict extubation success.
- Being tested
- comparaison between DE and DTF in prediction of extubation success
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparaison between DE and DTF in prediction of extubation successDiagnostic test
diaphragm ultrasound and measurement of DE and DTF in patients meeting all extubation criteria during spontaneous breathing trial
What is being measured
The primary outcome is the main question the study is designed to answer.
extubation success
comparaison between DE and DTF values in successfully extubated patients
Measured: 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Apr 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accuracy of DE and DTF in Prediction of Extubation SuccessStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
- Investigators
- Mhamed Sami Mebazaa, Professor, Principal investigator, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480828
- Sponsor's protocol ID
- rea1
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT03480828
- Acronym / sponsor ID
- rea1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 29 Mar 2018 (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.
This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation.
Detailed description
This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation. The investigators compared the median values of DE and DTF in the group of successfully extubated patients and the group of patients who needed reintubation.
Our study compared the utility of DTF and DE to predict extubation success.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who were mechanically ventilated for more than 48 hours and meeting all extubation criteria without a history of neuromuscular disease or severe chronic respiratory failure
Key inclusion criteria (2 listed)
- patients who were mechanically ventilated for more than 48h and meeting all criteria for extubation
- patients without history of neuromuscular disease, or severe chronic respiratory failure
Key exclusion criteria (1 listed)
- patients who needed reintubation for upper airway obstruction or neurological or hemodynamic instability
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 |
|---|---|---|
| comparaison between DE and DTF in prediction of extubation successdiaphragm ultrasound and measurement of DE and DTF in patients meeting all extubation criteria during spontaneous breathing trial | Diagnostic test | – |
Primary outcome
extubation success
Time frame: 48 hours after extubation
comparaison between DE and DTF values in successfully extubated patients
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 30 Mar 2018.
- Individual participant dataSharing planned: Undecided
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.
Mhamed Sami Mebazaa, Professor principal investigator
Mongi Slim Hospital
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 Accuracy of DE and DTF in Prediction of Extubation Success, run by Mongi Slim Hospital at 1 site in Tunisia.
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 2 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: finished, as of the sponsor's last update on 30 Mar 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 Tunisia. 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?
extubation success (time frame: 48 hours after extubation). 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 30 Mar 2018.