Weaning FailureNCT04825509
Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome
An observational study of Weaning Failure and Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to assess whether the degree of diaphragm excursion and diaphragm thickening measured by ultrasound during a weaning trial may be used to predict successful weaning from mechanical ventilation in patients with sepsis in intensive care unit Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Weaning Failure, Sepsis
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Apr 2021to 1 Nov 2021
- How long will I take part?
- 2 Days
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients will be intubated (for 2 - 7 days) and ready for weaning process. They will undergo diaphragmatic ultrasound on spontaneous breathing pattern on T-piece connected to 8L/min O2 with subsequent outcome either successful weaning or failed weaning
Who may be able to join
- Patients of both sexes, aging 18 - 60 years after written informed consent
- Patients with sepsis on admission according to the new sepsis definition in 2016 (life-threatening organ dysfunction due to a dysregulated host response to infection)
- Hemodynamically stable without or with low dose support
- Patients on mechanical ventilation for at least 48 hours and not more than 1 week
- Patients ready for start of weaning protocol, fully conscious, on continuous positive airway pressure (CPAP) mode with positive end expiratory pressure (PEEP) 3-5 Centimetre water (CmH2O), Pr. Supp. <15 CmH2O, Fio2 less than 60%, Respiratory rate less than 35 breath/min, partial oxygen pressure (PO2)/FIO2 >200, Rapid Shallow Breathing Index (RSBI) is less than 105
Who cannot join
- Patients aged less than 18 years or more than 60 years old
- Patients in septic shock, hemodynamically unstable or on high dose support
- Patients on mechanical ventilation for more than 1 week or less than 48 hours
- Patients not ready for start of weaning from mechanical ventilation
- Patients with neuromuscular disorders
- Pregnant females in the second and third trimester, patients with tense ascites or morbidly obese with body mass index more than 40 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome in Mechanically Ventilated Patients With Sepsis in Intensive Care Unit
This study aims to assess whether the degree of diaphragm excursion and diaphragm thickening measured by ultrasound during a weaning trial may be used to predict successful weaning from mechanical ventilation in patients with sepsis in intensive care unit
Read the detailed description
After being informed about the study and giving written informed consent, Intubated and mechanically ventilated patients with sepsis on admission and fulfilling criteria of weaning from mechanical ventilation (MV), will undergo diaphragm ultrasound during spontaneous breathing trial on T-piece. We will measure diaphragm excursion (DE), diaphragm thickness (DT) and calculate diaphragm thickness fraction (DTF):
DT during inspiration - DT during expiration / DT during expiration
According to weaning outcome, patients will be divided into 2 groups:
- Successful weaning group
- Weaning failure group
By statistical analysis we will define the cut off value and area under curve (AUC) for DE and DTF and we can confirm if DE and DTF using ultrasound can be used as predictors for weaning from MV or not
- Conditions
- Weaning Failure, Sepsis
- Being tested
- Ultrasound
- Keywords
- Diaphragm ultrasound, Weaning predictor
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Diaphragm ultrasound will be done while patient is supine on T-piece during SBT 30 minutes after disconnecting mechanical ventilation. The measurements will be done by placing the transducer in the eighth or ninth intercostal space, between the anterior axillary and the mid-axillary lines.
Diaphragmatic excursion (DE) will be measured in M-mode using a 1- to 5- Megahertz (MHz) ultrasound curved transducer during maximal breathing. The amplitude of diaphragmatic excursion will be measured as the point of maximal height of the diaphragm to the base line.
Diaphragmatic thickness (DT) will be measured at both end of maximal inspiration and end of maximal expiration using a high frequency 7-11 MHz ultrasound linear transducer in M-mode. The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line.
| Study group | Role | What they receive |
|---|---|---|
| Successful weaning group | Patients will be in this group according to primary outcome, if they will succeed spontaneous breathing trial for 120 minutes and will be extubated successfully without need for invasive or non-invasive ventilation for 48 hours Receives: Device: Ultrasound | |
| Weaning failure group | Patients will be in this group according to primary outcome, if they will fail spontaneous breathing trial or extubation within 48 hours
Weaning failure will be considered if:
* Patients will need MV during spontaneous breathing trial within 120 minutes, or
* patients will need invasive or non-invasive ventilation within 48 hours Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful extubation
extubation success or failure will depend on patient needs to MV during spontaneous breathing trial (SBT), or invasive or non-invasive ventilation within 48 hours after extubation according to: respiratory rate>35/min, increased work of breathing, O2 saturation <90% with fraction of inspired oxygen (FIO2)>50%, new arrhythmias, increased heart rate>20% or more than 140b/min, drop of 20 millimetre mercury (mmHg) or rise of 30 mmHg systolic blood pressure, increased systolic blood pressure >180 mmHg in normotensive patient, change of 10 mmHg diastolic blood pressure and deterioration of blood gases value
Measured: from start of SBT till 48 hours after extubation
Secondary outcomes (1)
need for tracheostomy
We will check patient need for tracheostomy since start of weaning process for 21 days and the indication for tracheostomy, if due to prolonged intubation or other causes
Measured: From start of SBT for 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start18 Apr 2021
- Primary completion17 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 60 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Saad, Ain Shams University
- Investigators
- Mohamed Saad, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825509
- Sponsor's protocol ID
- Diaphragm Ultrasound
- Status last verified
- Jul 2022
- First submitted
- 29 Mar 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data (IPD) that underlie the results reported in this article after deidentification (texts, tables, figures and appendices) will be available only for investigators whose purposed use of the data has been approved by an independent review committee identified for this purpose
Publications
Llamas-Alvarez AM, Tenza-Lozano EM, Latour-Perez J. Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis. Chest. 2017 Dec;152(6):1140-1150. doi: 10.1016/j.chest.2017.08.028. Epub 2017 Aug 31.
PubMed 28864053DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.
PubMed 24365607Kilaru D, Panebianco N, Baston C. Diaphragm Ultrasound in Weaning From Mechanical Ventilation. Chest. 2021 Mar;159(3):1166-1172. doi: 10.1016/j.chest.2020.12.003. Epub 2020 Dec 10.
PubMed 33309837
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome in Mechanically Ventilated Patients With Sepsis in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04825509
- Acronym / sponsor ID
- Diaphragm Ultrasound
- Conditions
- Weaning Failure, Sepsis
- Keywords
- Diaphragm ultrasound, Weaning predictor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Apr 2021 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 1 Apr 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.
This study aims to assess whether the degree of diaphragm excursion and diaphragm thickening measured by ultrasound during a weaning trial may be used to predict successful weaning from mechanical ventilation in patients with sepsis in intensive care unit
Detailed description
After being informed about the study and giving written informed consent, Intubated and mechanically ventilated patients with sepsis on admission and fulfilling criteria of weaning from mechanical ventilation (MV), will undergo diaphragm ultrasound during spontaneous breathing trial on T-piece. We will measure diaphragm excursion (DE), diaphragm thickness (DT) and calculate diaphragm thickness fraction (DTF):
DT during inspiration - DT during expiration / DT during expiration
According to weaning outcome, patients will be divided into 2 groups:
- Successful weaning group
- Weaning failure group
By statistical analysis we will define the cut off value and area under curve (AUC) for DE and DTF and we can confirm if DE and DTF using ultrasound can be used as predictors for weaning from MV or not
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful weaning group | – | Device: UltrasoundPatients will be in this group according to primary outcome, if they will succeed spontaneous breathing trial for 120 minutes and will be extubated successfully without need for invasive or non-invasive ventilation for 48 hours |
| Weaning failure group | – | Device: UltrasoundPatients will be in this group according to primary outcome, if they will fail spontaneous breathing trial or extubation within 48 hours Weaning failure will be considered if: * Patients will need MV during spontaneous breathing trial within 120 minutes, or * patients will need invasive or non-invasive ventilation within 48 hours |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients will be intubated (for 2 - 7 days) and ready for weaning process. They will undergo diaphragmatic ultrasound on spontaneous breathing pattern on T-piece connected to 8L/min O2 with subsequent outcome either successful weaning or failed weaning
Key inclusion criteria (5 listed)
- Patients of both sexes, aging 18 - 60 years after written informed consent
- Patients with sepsis on admission according to the new sepsis definition in 2016 (life-threatening organ dysfunction due to a dysregulated host response to infection)
- Hemodynamically stable without or with low dose support
- Patients on mechanical ventilation for at least 48 hours and not more than 1 week
- Patients ready for start of weaning protocol, fully conscious, on continuous positive airway pressure (CPAP) mode with positive end expiratory pressure (PEEP) 3-5 Centimetre water (CmH2O), Pr. Supp. <15 CmH2O, Fio2 less than 60%, Respiratory rate less than 35 breath/min, partial oxygen pressure (PO2)/FIO2 >200, Rapid Shallow Breathing Index (RSBI) is less than 105
Key exclusion criteria (6 listed)
- Patients aged less than 18 years or more than 60 years old
- Patients in septic shock, hemodynamically unstable or on high dose support
- Patients on mechanical ventilation for more than 1 week or less than 48 hours
- Patients not ready for start of weaning from mechanical ventilation
- Patients with neuromuscular disorders
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 |
|---|---|---|
| UltrasoundDiaphragm ultrasound will be done while patient is supine on T-piece during SBT 30 minutes after disconnecting mechanical ventilation. The measurements will be done by placing the transducer in the eighth or ninth intercostal space, between the anterior axillary and the mid-axillary lines. Diaphragmatic excursion (DE) will be measured in M-mode using a 1- to 5- Megahertz (MHz) ultrasound curved transducer during maximal breathing. The amplitude of diaphragmatic excursion will be measured as the point of maximal height of the diaphragm to the base line. Diaphragmatic thickness (DT) will be measured at both end of maximal inspiration and end of maximal expiration using a high frequency 7-11 MHz ultrasound linear transducer in M-mode. The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. | Device | Successful weaning group, Weaning failure group |
Primary outcome
Successful extubation
Time frame: from start of SBT till 48 hours after extubation
extubation success or failure will depend on patient needs to MV during spontaneous breathing trial (SBT), or invasive or non-invasive ventilation within 48 hours after extubation according to: respiratory rate>35/min, increased work of breathing, O2 saturation <90% with fraction of inspired oxygen (FIO2)>50%, new arrhythmias, increased heart rate>20% or more than 140b/min, drop of 20 millimetre mercury (mmHg) or rise of 30 mmHg systolic blood pressure, increased systolic blood pressure >180 mmHg in normotensive patient, change of 10 mmHg diastolic blood pressure and deterioration of blood gases value
1 secondary outcome
need for tracheostomy
Time frame: From start of SBT for 21 days
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 21 Jul 2022.
- Background: PubMed 28864053Llamas-Alvarez AM, Tenza-Lozano EM, Latour-Perez J. Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis. Chest. 2017 Dec;152(6):1140-1150. doi: 10.1016/j.chest.2017.08.028. Epub 2017 Aug 31.
- Background: PubMed 24365607DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.
- Background: PubMed 33309837Kilaru D, Panebianco N, Baston C. Diaphragm Ultrasound in Weaning From Mechanical Ventilation. Chest. 2021 Mar;159(3):1166-1172. doi: 10.1016/j.chest.2020.12.003. Epub 2020 Dec 10.
- Individual participant dataSharing planned: No. Individual patient data (IPD) that underlie the results reported in this article after deidentification (texts, tables, figures and appendices) will be available only for investigators whose purposed use of the data has been approved by an independent review committee identified for this purpose
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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.
Mohamed Saad principal investigator
Ain Shams 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 Weaning Failure and Sepsis, run by Ain Shams 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 5 inclusion and 6 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 21 Jul 2022. 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?
Successful extubation (time frame: from start of SBT till 48 hours after extubation). 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 NCT04825509, which also lists 3 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 21 Jul 2022.