Liberation From Mechanical Ventilation in ICU PatientsNCT06461754
Prediction of Successful Liberation From Invasive Mechanical Ventilation Via Lung and Diaphragmatic Ultrasound in Intensive Care Unit Patients, Prospective, Observational Study
An observational study of Liberation From Mechanical Ventilation in ICU Patients, run by Sohag University at 1 site in Egypt.
Trial summary
Liberation from invasive mechanical ventilation (IMV) remains a challenge for intensive care physicians. Although standard indices such as blood gases and respiratory clinical data are used routinely but they still have some limitations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liberation From Mechanical Ventilation in ICU Patients
- What is being tested?
- Sonographic evaluation of diaphragm and lung
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2022to 20 Dec 2023
- 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: 80 patients who were admitted to the ICU and on invasive mechanical ventilation for more than 24 hours and ready for weaning
Who may be able to join
- Over 18 years of age, more than 24 hours on IMV, and prepared for weaning
Who cannot join
- A spinal cord injury that exceeded T8, arrhythmias, heart failure, hemodynamic instability, terminal extubation, pregnancy, pneumothorax, pneumomediastinum, COPD, thoracostomy, chest injuries that impeded ultrasound, pleural lesions, or neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Liberation from invasive mechanical ventilation (IMV) remains a challenge for intensive care physicians. Although standard indices such as blood gases and respiratory clinical data are used routinely but they still have some limitations. Diaphragmatic and lung sonographic parameters (pulmonary scores) recently became the hot spot to help in anticipation of liberation from IMV.The aim of this study was to ensure that, sonographic diaphragmatic thickening indices and lung scores are reliable and accurate additional tools to anticipate successful liberation from IMV in intensive care unit (ICU) patients.
Methods: This study was a prospective, observational study conducted at Sohag university hospital on 80 patients admitted to the Intensive Care Unit (ICU) and mechanically ventilated invasively for more than 24 hours and they were ready for weaning by standard methods. At the time of spontaneous breathing trials (SBT), we did diaphragm and lung ultrasound, where we applied diaphragmatic thickening indices (DTI) and a modified lung ultrasound scores (LUSm). Patients classified into two groups; failed group (FG) and (SG) of liberation from IMV. Comparison between (FG) and (SG) in relation to pulmonary scores (DTI and LUSm) were recorded. Cut-off values, sensitivity and specificity for DTI and LUSm were obtained. Also, comparison between (FG) and (SG) in relation to demographic, clinical and respiratory data were assessed and all data were statistically analysed.
- Being tested
- Sonographic evaluation of diaphragm and lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonographic evaluation of diaphragm and lungOther
While the patient in a semi-sitting position (20-40 degree), by ultrasound, the diaphragm thickness was measured in the zone of apposition, on the mid-axillary line among the 8th and 10th intercostal spaces, using a 7-10 MHz linear probe in (M) mode. at the end of expiration and at the end of inspiration by capturing nearly three images during spontaneous patient breathing. The average of three DTI measurements was calculated In lung ultrasound, 2-4 MHz convex ultrasound probe in (B) mode was employed. We implemented a modified LUSm in our investigation, which assessed four lung regions on each side.
| Study group | Role | What they receive |
|---|---|---|
| Succeeded Group (SG) | Group of patients who succeeded weaning from mechanical ventilation Receives: Other: Sonographic evaluation of diaphragm and lung | |
| Failed Group (FG) | Group of patients who failed weaning from mechanical ventilation Receives: Other: Sonographic evaluation of diaphragm and lung |
What is being measured
The primary outcome is the main question the study is designed to answer.
a cut off values for DTI and LUSm with sensitivity and specificity for anticipation of liberation from invasive mechanical ventilation
we reporte a cut-off value for DTI and LUSm below or above which the risk for failure of weaning can be predicted with a sensitivity persent and a specificity persent.
Measured: One year
Secondary outcomes (1)
The correlations of DTI and LUSm with demographic, clinical and respiratory data
We recorded the relations of DTI and LUSm with demographic, clinical and respiratory data in prediction of succeeded liberation from IMV
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 posted17 Jun 2024
- Study start21 Sep 2022
- Primary completion20 Oct 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liberation From Mechanical Ventilation in ICU PatientsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fawzy Abbas Badawy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461754
- Sponsor's protocol ID
- Soh-Med-22-09-20
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes
Publications
Tenza-Lozano E, Llamas-Alvarez A, Jaimez-Navarro E, Fernandez-Sanchez J. Lung and diaphragm ultrasound as predictors of success in weaning from mechanical ventilation. Crit Ultrasound J. 2018 Jun 18;10(1):12. doi: 10.1186/s13089-018-0094-3.
PubMed 29911284Gok F, Mercan A, Kilicaslan A, Sarkilar G, Yosunkaya A. Diaphragm and Lung Ultrasonography During Weaning From Mechanical Ventilation in Critically Ill Patients. Cureus. 2021 May 16;13(5):e15057. doi: 10.7759/cureus.15057.
PubMed 34007779Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22.
PubMed 27112953Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
PubMed 24949192
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Successful Liberation From Invasive Mechanical Ventilation Via Lung and Diaphragmatic Ultrasound in Intensive Care Unit Patients, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06461754
- Acronym / sponsor ID
- Soh-Med-22-09-20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 17 Jun 2024 (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.
Liberation from invasive mechanical ventilation (IMV) remains a challenge for intensive care physicians. Although standard indices such as blood gases and respiratory clinical data are used routinely but they still have some limitations. Diaphragmatic and lung sonographic parameters (pulmonary scores) recently became the hot spot to help in anticipation of liberation from IMV.The aim of this study was to ensure that, sonographic diaphragmatic thickening indices and lung scores are reliable and accurate additional tools to anticipate successful liberation from IMV in intensive care unit (ICU) patients.
Methods: This study was a prospective, observational study conducted at Sohag university hospital on 80 patients admitted to the Intensive Care Unit (ICU) and mechanically ventilated invasively for more than 24 hours and they were ready for weaning by standard methods. At the time of spontaneous breathing trials (SBT), we did diaphragm and lung ultrasound, where we applied diaphragmatic thickening indices (DTI) and a modified lung ultrasound scores (LUSm). Patients classified into two groups; failed group (FG) and (SG) of liberation from IMV. Comparison between (FG) and (SG) in relation to pulmonary scores (DTI and LUSm) were recorded. Cut-off values, sensitivity and specificity for DTI and LUSm were obtained. Also, comparison between (FG) and (SG) in relation to demographic, clinical and respiratory data were assessed and all data were statistically analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Succeeded Group (SG) | – | Other: Sonographic evaluation of diaphragm and lungGroup of patients who succeeded weaning from mechanical ventilation |
| Failed Group (FG) | – | Other: Sonographic evaluation of diaphragm and lungGroup of patients who failed weaning from mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 patients who were admitted to the ICU and on invasive mechanical ventilation for more than 24 hours and ready for weaning
Key inclusion criteria (1 listed)
- Over 18 years of age, more than 24 hours on IMV, and prepared for weaning
Key exclusion criteria (1 listed)
- A spinal cord injury that exceeded T8, arrhythmias, heart failure, hemodynamic instability, terminal extubation, pregnancy, pneumothorax, pneumomediastinum, COPD, thoracostomy, chest injuries that impeded ultrasound, pleural lesions, or neuromuscular diseases
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 |
|---|---|---|
| Sonographic evaluation of diaphragm and lungWhile the patient in a semi-sitting position (20-40 degree), by ultrasound, the diaphragm thickness was measured in the zone of apposition, on the mid-axillary line among the 8th and 10th intercostal spaces, using a 7-10 MHz linear probe in (M) mode. at the end of expiration and at the end of inspiration by capturing nearly three images during spontaneous patient breathing. The average of three DTI measurements was calculated In lung ultrasound, 2-4 MHz convex ultrasound probe in (B) mode was employed. We implemented a modified LUSm in our investigation, which assessed four lung regions on each side. | Other | Failed Group (FG), Succeeded Group (SG) |
Primary outcome
a cut off values for DTI and LUSm with sensitivity and specificity for anticipation of liberation from invasive mechanical ventilation
Time frame: One year
we reporte a cut-off value for DTI and LUSm below or above which the risk for failure of weaning can be predicted with a sensitivity persent and a specificity persent.
1 secondary outcome
The correlations of DTI and LUSm with demographic, clinical and respiratory data
Time frame: one year
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 26 Jun 2024.
- Background: PubMed 29911284Tenza-Lozano E, Llamas-Alvarez A, Jaimez-Navarro E, Fernandez-Sanchez J. Lung and diaphragm ultrasound as predictors of success in weaning from mechanical ventilation. Crit Ultrasound J. 2018 Jun 18;10(1):12. doi: 10.1186/s13089-018-0094-3.
- Background: PubMed 34007779Gok F, Mercan A, Kilicaslan A, Sarkilar G, Yosunkaya A. Diaphragm and Lung Ultrasonography During Weaning From Mechanical Ventilation in Critically Ill Patients. Cureus. 2021 May 16;13(5):e15057. doi: 10.7759/cureus.15057.
- Background: PubMed 27112953Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22.
- Background: PubMed 24949192Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
- Individual participant dataSharing planned: Yes
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.
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 Liberation From Mechanical Ventilation in ICU Patients, run by Sohag 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 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 26 Jun 2024. 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?
a cut off values for DTI and LUSm with sensitivity and specificity for anticipation of liberation from invasive mechanical ventilation (time frame: One year). 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 NCT06461754, which also lists 4 linked publications.
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 26 Jun 2024.