Left Ventricular Diastolic DysfunctionNCT04703387
Left Ventricular Diastolic Dysfunction as a Predictor of Weaning Failure From Mechanical Ventilation
An observational study of Left Ventricular Diastolic Dysfunction and Weaning Failure, run by Tanta University at 1 site in Egypt.
Trial summary
Both premature and delayed extubation prolong the duration of mechanical ventilation and the intensive care unit (ICU) length of stay and increase morbidity and mortality. Therefore, accurate prediction of postextubation distress and the early diagnosis of the causes responsible for failure of a trial of pressure… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Ventricular Diastolic Dysfunction, Weaning Failure, Mechanical Ventilation Complication
- What is being tested?
- transthoracic echocardiography
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 31 Dec 2022
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients aged more than 40 years who are intubated and mechanically ventilated for more than 48 hours, with improvement of underlying cause of acute respiratory failure and considered ready to undergo a spontaneous breathing trial (SBT) by the attending physician on the basis of readiness-to-wean criteria used in our surgical ICUn Criteria
Who may be able to join
None listed.
Who cannot join
- Planning for tracheostomy after the SBT.
- Severe mitral stenosis, severe regurgitation, or prosthetic mitral valve.
- History of diaphragmatic dysfunction as diaphragmatic palsy, cervical spine injury, or neuromuscular disease.
- Pneumothorax or pneumo-mediastinum.
- Use of muscle-paralyzing agents within 48 h before the study.
- Poor echocardiographic windows or difficult windows of diaphragmatic movement as women in late pregnancy or obese patients.
Show all 10Show fewer
- Extubation failure definitely caused by upper airway obstruction.
- Planned prophylactic noninvasive ventilation (NIV) after extubation.
- Atrial fibrillation or atrioventricular conduction abnormality.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study on Left Ventricular Diastolic Dysfunction as a Predictor of Weaning Failure From Mechanical Ventilation
Both premature and delayed extubation prolong the duration of mechanical ventilation and the intensive care unit (ICU) length of stay and increase morbidity and mortality. Therefore, accurate prediction of postextubation distress and the early diagnosis of the causes responsible for failure of a trial of pressure support ventilation are of paramount importance to improve the outcome of mechanically ventilated patients in the ICU.
This observational study is designed to test the ability of cardiac and diaphragm function assessed by bedside ultrasound to predict extubation failure within 48 h and re-intubation within 1 week after extubation.
Read the detailed description
Weaning from mechanical ventilation is the process of gradual ventilatory support reduction to the patient subjected to mechanical ventilation for more than 24 hours. Determining the correct time to extubate mechanically ventilated patients is a crucial issue in the critical care practice.
Spontaneous breathing trial (SBT) is recommended to predict weaning outcome. However, 13% to 26% of patients who are extubated following a successful SBT need to be reintubated within 48 hours.
Traditional indicators, such as respiratory rate (RR), minute ventilation, tidal volume (VT), and the rapid shallow breathing index (RSBI), can reflect patients' integral conditions, but none has shown great prognostic accuracy for weaning failure.
Although there are several causes of weaning failure, cardiac function deterioration during the weaning process combined with acute pulmonary edema is considered the leading cause of weaning failure. The transition from positive to negative thoracic pressure increases venous return and left ventricular afterload, decreases left ventricular compliance and may induce cardiac ischemia. All of these factors tend to increase ventricular filling pressures and may consequently lead to weaning-induced pulmonary edema. The efficacy of echocardiography for predicting weaning failure has been reported, however there is debate over the predictive value of echocardiography in this setting continues due to differences in weaning technique and outcome evaluation.
The diaphragm is the principal respiratory muscle. With an excursion of 1 to 2 cm, it provides nearly 75% of the resting pulmonary ventilation, while during the forced breathing, its amplitude is up to 7 to 11 cm. However, the diaphragm is vulnerable to damage from hypotension, hypoxia, and sepsis, which are very common in critically ill patients. While in surgical patients, diaphragm dysfunction is often caused by acute insults such as trauma or surgical procedures. In addition, mechanical ventilation itself can decrease the force of the diaphragm and induce diaphragmatic dysfunction, named as ventilator-induced diaphragmatic dysfunction. Many studies have shown that Diaphragm dysfunction is responsible for a number of pulmonary complications, including atelectasis and pneumonia, which are risk factors for extubation failure. and might lead to weaning failure and long-term mechanical ventilation.
Some studies have reported that diaphragmatic excursion (DE) or and diaphragmatic thickening fraction (DTF) could predict extubation failure.
Although transthoracic echocardiography and diaphragm ultrasound have been confirmed in independently assessing extubation outcomes, few studies have shown their different roles in the weaning process until now.
- Conditions
- Left Ventricular Diastolic Dysfunction, Weaning Failure, Mechanical Ventilation Complication, Diaphragmatic Disorder
- Being tested
- transthoracic echocardiography
- Keywords
- Mechanical Ventilation Complication, Left Ventricular Diastolic Dysfunction, Pulmonary Edema, echocardiography
- Medical subject headings
- Ventricular Dysfunction, Left, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiographyDiagnostic test
Also called diaphragm ultrasonographic
Trans-mitral flow velocities (peak early diastolic E and peak late diastolic A) will be recorded with pulsed-wave Doppler, placing the sample volume at the mitral valve tips from the apical 4-chamber view; deceleration time of the E wave (DTE) will be measured. Peak early diastolic velocity will be obtained with tissue Doppler imaging (TDI), in the apical 4-chamber view, positioning the pulsed-wave Doppler sample volume at or 1 cm within the septal insertion sites of the mitral leaflets, so as to cover the longitudinal excursion of the mitral annulus in both systole and diastole. Then, the E/A ratio and the trans-mitral inflow E wave to mitral annular e' (E/e) will be calculated.Diaphragmatic thickness will be assessed in the zone of apposition of the diaphragm to the rib cage between the 8th and 10th intercostal spaces using a 3-12 MHz linear array probe , we will record changes in diaphragm vertical excursion using M-mode ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Postextubation Success | Not described Receives: Diagnostic Test: transthoracic echocardiography | |
| Postextubation Distress | Not described Receives: Diagnostic Test: transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning failure
Weaning failure predicted by diastolic dysfunction assessed by E/Ea.
Measured: within 48 hours after extubation
Secondary outcomes (1)
Weaning failure
Weaning failure predicted by Diaphragmatic function assessment
Measured: within 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 posted11 Jan 2021
- Study start1 Aug 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Diastolic DysfunctionStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Azzam Abdellatif Elsayed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703387
- Sponsor's protocol ID
- 33855/6/20
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2021
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- 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 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Left Ventricular Diastolic Dysfunction as a Predictor of Weaning Failure From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04703387
- Acronym / sponsor ID
- 33855/6/20
- Conditions
- Left Ventricular Diastolic Dysfunction, Weaning Failure, Mechanical Ventilation Complication, Diaphragmatic Disorder
- Keywords
- Mechanical Ventilation Complication, Left Ventricular Diastolic Dysfunction, Pulmonary Edema, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Jan 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.
Both premature and delayed extubation prolong the duration of mechanical ventilation and the intensive care unit (ICU) length of stay and increase morbidity and mortality. Therefore, accurate prediction of postextubation distress and the early diagnosis of the causes responsible for failure of a trial of pressure support ventilation are of paramount importance to improve the outcome of mechanically ventilated patients in the ICU.
This observational study is designed to test the ability of cardiac and diaphragm function assessed by bedside ultrasound to predict extubation failure within 48 h and re-intubation within 1 week after extubation.
Detailed description
Weaning from mechanical ventilation is the process of gradual ventilatory support reduction to the patient subjected to mechanical ventilation for more than 24 hours. Determining the correct time to extubate mechanically ventilated patients is a crucial issue in the critical care practice.
Spontaneous breathing trial (SBT) is recommended to predict weaning outcome. However, 13% to 26% of patients who are extubated following a successful SBT need to be reintubated within 48 hours.
Traditional indicators, such as respiratory rate (RR), minute ventilation, tidal volume (VT), and the rapid shallow breathing index (RSBI), can reflect patients' integral conditions, but none has shown great prognostic accuracy for weaning failure.
Although there are several causes of weaning failure, cardiac function deterioration during the weaning process combined with acute pulmonary edema is considered the leading cause of weaning failure. The transition from positive to negative thoracic pressure increases venous return and left ventricular afterload, decreases left ventricular compliance and may induce cardiac ischemia. All of these factors tend to increase ventricular filling pressures and may consequently lead to weaning-induced pulmonary edema. The efficacy of echocardiography for predicting weaning failure has been reported, however there is debate over the predictive value of echocardiography in this setting continues due to differences in weaning technique and outcome evaluation.
The diaphragm is the principal respiratory muscle. With an excursion of 1 to 2 cm, it provides nearly 75% of the resting pulmonary ventilation, while during the forced breathing, its amplitude is up to 7 to 11 cm. However, the diaphragm is vulnerable to damage from hypotension, hypoxia, and sepsis, which are very common in critically ill patients. While in surgical patients, diaphragm dysfunction is often caused by acute insults such as trauma or surgical procedures. In addition, mechanical ventilation itself can decrease the force of the diaphragm and induce diaphragmatic dysfunction, named as ventilator-induced diaphragmatic dysfunction. Many studies have shown that Diaphragm dysfunction is responsible for a number of pulmonary complications, including atelectasis and pneumonia, which are risk factors for extubation failure. and might lead to weaning failure and long-term mechanical ventilation.
Some studies have reported that diaphragmatic excursion (DE) or and diaphragmatic thickening fraction (DTF) could predict extubation failure.
Although transthoracic echocardiography and diaphragm ultrasound have been confirmed in independently assessing extubation outcomes, few studies have shown their different roles in the weaning process until now.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postextubation Success | – | Diagnostic Test: transthoracic echocardiography |
| Postextubation Distress | – | Diagnostic Test: transthoracic echocardiography |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged more than 40 years who are intubated and mechanically ventilated for more than 48 hours, with improvement of underlying cause of acute respiratory failure and considered ready to undergo a spontaneous breathing trial (SBT) by the attending physician on the basis of readiness-to-wean criteria used in our surgical ICUn Criteria
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Planning for tracheostomy after the SBT.
- Severe mitral stenosis, severe regurgitation, or prosthetic mitral valve.
- History of diaphragmatic dysfunction as diaphragmatic palsy, cervical spine injury, or neuromuscular disease.
- Pneumothorax or pneumo-mediastinum.
- Use of muscle-paralyzing agents within 48 h before the study.
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 |
|---|---|---|
| transthoracic echocardiographyAlso: diaphragm ultrasonographicTrans-mitral flow velocities (peak early diastolic E and peak late diastolic A) will be recorded with pulsed-wave Doppler, placing the sample volume at the mitral valve tips from the apical 4-chamber view; deceleration time of the E wave (DTE) will be measured. Peak early diastolic velocity will be obtained with tissue Doppler imaging (TDI), in the apical 4-chamber view, positioning the pulsed-wave Doppler sample volume at or 1 cm within the septal insertion sites of the mitral leaflets, so as to cover the longitudinal excursion of the mitral annulus in both systole and diastole. Then, the E/A ratio and the trans-mitral inflow E wave to mitral annular e' (E/e) will be calculated.Diaphragmatic thickness will be assessed in the zone of apposition of the diaphragm to the rib cage between the 8th and 10th intercostal spaces using a 3-12 MHz linear array probe , we will record changes in diaphragm vertical excursion using M-mode ultrasound. | Diagnostic test | Postextubation Distress, Postextubation Success |
Primary outcome
Weaning failure
Time frame: within 48 hours after extubation
Weaning failure predicted by diastolic dysfunction assessed by E/Ea.
1 secondary outcome
Weaning failure
Time frame: within 48 hours after extubation
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 27 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Left Ventricular Diastolic Dysfunction and Weaning Failure, run by Tanta 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 0 inclusion and 10 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 27 Feb 2023. 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?
Weaning failure (time frame: within 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 27 Feb 2023; AzTrials last refreshed its copy on 26 Oct 2026.