Diaphragmatic Ultrasound in WeaningNCT03608332
Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation
A study testing diaphragmatic ultrasound in people with Diaphragmatic Ultrasound in Weaning, run by Cairo University at 1 site in Egypt.
Trial summary
To assess value of adding ultrasound derived variables to the usual parameters on success rate of weaning from mechanical ventilation in critically ill patients and to validate sensitivity and specificity of ultrasound derived variables (thickening fraction /diaphragmatic excursion) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragmatic Ultrasound in Weaning
- What is being tested?
- diaphragmatic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2018to 29 Sep 2019
- Phase
- Interventional
- 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
Who may be able to join
- Critically ill patients intubated for more than 48 hours who are ready for weaning
Who cannot join
- • Age < 18 years
- surgical dressings over the right lower rib cage which would preclude ultrasound examination
- patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic injury and diaphragmatic surgery
- patients with neuromuscular diseases ( myasthenia gravis ,Muscular dystrophies ,Multiple sclerosis and Amyotrophic lateral sclerosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation (Randomized Controlled Trial)
To assess value of adding ultrasound derived variables to the usual parameters on success rate of weaning from mechanical ventilation in critically ill patients and to validate sensitivity and specificity of ultrasound derived variables (thickening fraction /diaphragmatic excursion)
Read the detailed description
Difficult weaning from mechanical ventilation (MV) is a common problem in critically ill patients. Many parameters have been developed to aid weaning from MV such as P/F ratio (PO2/FiO2) and rapid shallow breathing index (respiratory rate/tidal volume), however, sensitivity and specificity for most variables are still variable in literature.
Multiple studies have found that patients tolerantof SBTs were found to have successful discontinuationsat least 77% of the time.
Causes of weaning failure include: airway and lung dysfunction, brain dysfunction, cardiac dysfunction, diaphragm dysfunction, and endocrine dysfunction .
Diaphragmatic dysfunction is a common cause of weaning failure , however most of the traditional methods used for evaluation of diaphragmatic function (fluoroscopy, trans-diaphragmatic pressure measurement) are invasive and not available.
Ultrasound assessment of diaphragmatic function has been developed recently providing an easy and safe method for evaluation of diaphragmatic excursion and thickening.
It was found that weaning failure (Re-intubation within 48 hours) was associated with diaphragmatic excursion <1 cm and thickening fraction <28% several studies reported the value of diaphragmatic ultrasound to predict weaning failure ,however no one of them used diaphragmatic ultrasound to guide weaning.
previous studies showed that failure rate of weaning from mechanical ventilation was 27% ,however failure rate in our department was 43% adding ultrasound derived values aims for improving success rate of weaning from mechanical ventilation.
- Conditions
- Diaphragmatic Ultrasound in Weaning
- Being tested
- diaphragmatic ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic ultrasoundDevice
Diaphragmatic excursion; Diaphragmatic movement will be measured with a 3.5-MHz US probe (Mindray machine, DC-N6).
| Study group | Role | What they receive |
|---|---|---|
| Group S | No intervention | weaning readiness will be evaluated with the standard criteria :- A) Clinical assessment:- * Resolution of acute phase of disease for which patient was intubated * Adequate cough * Absence of excessive tracheobronchial secretions B) Objective criteria:- * Adequate oxygenation:PaO2>60mmHg with PEEP<8,SaO2>90%,FIO2 <0.5,PaO2/FIO2>200 * Respiratory rate <30 * PH and PaCO2 appropriate for patients' baseline respiratory status * Hemodynamically stable :minimal or no vasopressor/inotropes,no evidence of myocardial ischemia * HR<140 beats/minute * Patient is arousable or Glasgow coma scale (GCS)>13 |
| Group SD | Experimental | weaning readiness will be evaluated with the following criteria:- A) Clinical assessment:-
* Resolution of acute phase of disease for which patient was intubated
* Adequate cough
* Absence of excessive tracheobronchial secretions
B) Objective criteria:-
* Adequate oxygenation:PaO2>60mmHg with PEEP<8,SaO2>90%,FIO2 <0.5,PaO2/FIO2>200
* Respiratory rate <30
* PH and PaCO2 appropriate for patients' baseline respiratory status
* Hemodynamically stable :minimal or no vasopressor/inotropes,no evidence of myocardial ischemia
* HR<140 beats/minute
* Patient is arousable or Glasgow coma scale (GCS)>13
C) Ultrasound criteria:-
• Diaphragmatic excursion >11 mm Receives: Device: diaphragmatic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of weaning from mechanical ventilation in both groups
(The trial will be considered a successful weaning trial if the patient passed 48 hours without the need for neither invasive nor non-invasive ventilation)
Measured: 48 Hours after weaning
Secondary outcomes (3)
• Rapid shallow breathing index (RSBI) and its correlation with ultrasound derived variables
Measured: baseline
• Days of ventilation (before weaning trial) in correlation to diaphragmatic dysfunction
Measured: baseline
• Number of weaning trials prior to inclusion in the study
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start30 Apr 2018
- Primary completion29 Sep 2019
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diaphragmatic Ultrasound in WeaningStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
- Investigators
- ahmed mohamed moukhtar, MD, Principal investigator, professor of anesthesiology cairo universitywaleed ibrahim Hamimmy, MD, Principal investigator, professor of anesthesiology cairo universityakram shahat Eladawy, MD, Principal investigator, assistant professor of anesthesiology cairo universityahmed muhamed lotfy, MD, Principal investigator, lecturer of anesthesiology cairo universitymina adolf helmy, MSc, Principal investigator, assistant lecturer of anesthesiology cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608332
- Sponsor's protocol ID
- DUS in weaning
- Status last verified
- Sep 2019
- First submitted
- 24 Jul 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El-Khatib MF, Bou-Khalil P. Clinical review: liberation from mechanical ventilation. Crit Care. 2008;12(4):221. doi: 10.1186/cc6959. Epub 2008 Aug 6.
PubMed 18710593MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.
PubMed 11742959Fagon JY, Chastre J, Hance AJ, Montravers P, Novara A, Gibert C. Nosocomial pneumonia in ventilated patients: a cohort study evaluating attributable mortality and hospital stay. Am J Med. 1993 Mar;94(3):281-8. doi: 10.1016/0002-9343(93)90060-3.
PubMed 8452152Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.
PubMed 7823995Heunks LM, van der Hoeven JG. Clinical review: the ABC of weaning failure--a structured approach. Crit Care. 2010;14(6):245. doi: 10.1186/cc9296. Epub 2010 Dec 8.
PubMed 21143773Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
PubMed 23344830Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.
PubMed 21705883Ferrari 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 24949192DiNino 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 24365607Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.
PubMed 9927366Jiang JR, Tsai TH, Jerng JS, Yu CJ, Wu HD, Yang PC. Ultrasonographic evaluation of liver/spleen movements and extubation outcome. Chest. 2004 Jul;126(1):179-85. doi: 10.1378/chest.126.1.179.
PubMed 15249460
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Ultrasound as a Guide Tool During Weaning From Mechanical Ventilation (Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT03608332
- Acronym / sponsor ID
- DUS in weaning
- Conditions
- Diaphragmatic Ultrasound in Weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 29 Sep 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 31 Jul 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.
To assess value of adding ultrasound derived variables to the usual parameters on success rate of weaning from mechanical ventilation in critically ill patients and to validate sensitivity and specificity of ultrasound derived variables (thickening fraction /diaphragmatic excursion)
Detailed description
Difficult weaning from mechanical ventilation (MV) is a common problem in critically ill patients. Many parameters have been developed to aid weaning from MV such as P/F ratio (PO2/FiO2) and rapid shallow breathing index (respiratory rate/tidal volume), however, sensitivity and specificity for most variables are still variable in literature.
Multiple studies have found that patients tolerantof SBTs were found to have successful discontinuationsat least 77% of the time.
Causes of weaning failure include: airway and lung dysfunction, brain dysfunction, cardiac dysfunction, diaphragm dysfunction, and endocrine dysfunction .
Diaphragmatic dysfunction is a common cause of weaning failure , however most of the traditional methods used for evaluation of diaphragmatic function (fluoroscopy, trans-diaphragmatic pressure measurement) are invasive and not available.
Ultrasound assessment of diaphragmatic function has been developed recently providing an easy and safe method for evaluation of diaphragmatic excursion and thickening.
It was found that weaning failure (Re-intubation within 48 hours) was associated with diaphragmatic excursion <1 cm and thickening fraction <28% several studies reported the value of diaphragmatic ultrasound to predict weaning failure ,however no one of them used diaphragmatic ultrasound to guide weaning.
previous studies showed that failure rate of weaning from mechanical ventilation was 27% ,however failure rate in our department was 43% adding ultrasound derived values aims for improving success rate of weaning from mechanical ventilation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | No intervention | –weaning readiness will be evaluated with the standard criteria :- A) Clinical assessment:- * Resolution of acute phase of disease for which patient was intubated * Adequate cough * Absence of excessive tracheobronchial secretions B) Objective criteria:- * Adequate oxygenation:PaO2>60mmHg with PEEP<8,SaO2>90%,FIO2 <0.5,PaO2/FIO2>200 * Respiratory rate <30 * PH and PaCO2 appropriate for patients' baseline respiratory status * Hemodynamically stable :minimal or no vasopressor/inotropes,no evidence of myocardial ischemia * HR<140 beats/minute * Patient is arousable or Glasgow coma scale (GCS)>13 |
| Group SD | Experimental | Device: diaphragmatic ultrasoundweaning readiness will be evaluated with the following criteria:- A) Clinical assessment:- * Resolution of acute phase of disease for which patient was intubated * Adequate cough * Absence of excessive tracheobronchial secretions B) Objective criteria:- * Adequate oxygenation:PaO2>60mmHg with PEEP<8,SaO2>90%,FIO2 <0.5,PaO2/FIO2>200 * Respiratory rate <30 * PH and PaCO2 appropriate for patients' baseline respiratory status * Hemodynamically stable :minimal or no vasopressor/inotropes,no evidence of myocardial ischemia * HR<140 beats/minute * Patient is arousable or Glasgow coma scale (GCS)>13 C) Ultrasound criteria:- • Diaphragmatic excursion >11 mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critically ill patients intubated for more than 48 hours who are ready for weaning
Key exclusion criteria (4 listed)
- • Age < 18 years
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 |
|---|---|---|
| diaphragmatic ultrasoundDiaphragmatic excursion; Diaphragmatic movement will be measured with a 3.5-MHz US probe (Mindray machine, DC-N6). | Device | Group SD |
Primary outcome
Success rate of weaning from mechanical ventilation in both groups
Time frame: 48 Hours after weaning
(The trial will be considered a successful weaning trial if the patient passed 48 hours without the need for neither invasive nor non-invasive ventilation)
3 secondary outcomes
• Rapid shallow breathing index (RSBI) and its correlation with ultrasound derived variables
Time frame: baseline
• Days of ventilation (before weaning trial) in correlation to diaphragmatic dysfunction
Time frame: baseline
• Number of weaning trials prior to inclusion in the study
Time frame: baseline
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 1 Oct 2019.
- Background: PubMed 18710593El-Khatib MF, Bou-Khalil P. Clinical review: liberation from mechanical ventilation. Crit Care. 2008;12(4):221. doi: 10.1186/cc6959. Epub 2008 Aug 6.
- Background: PubMed 11742959MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.
- Background: PubMed 8452152Fagon JY, Chastre J, Hance AJ, Montravers P, Novara A, Gibert C. Nosocomial pneumonia in ventilated patients: a cohort study evaluating attributable mortality and hospital stay. Am J Med. 1993 Mar;94(3):281-8. doi: 10.1016/0002-9343(93)90060-3.
- Background: PubMed 7823995Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.
- Background: PubMed 21143773Heunks LM, van der Hoeven JG. Clinical review: the ABC of weaning failure--a structured approach. Crit Care. 2010;14(6):245. doi: 10.1186/cc9296. Epub 2010 Dec 8.
- Background: PubMed 23344830Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
- Background: PubMed 21705883Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.
- 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.
- 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 9927366Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.
- Background: PubMed 15249460Jiang JR, Tsai TH, Jerng JS, Yu CJ, Wu HD, Yang PC. Ultrasonographic evaluation of liver/spleen movements and extubation outcome. Chest. 2004 Jul;126(1):179-85. doi: 10.1378/chest.126.1.179.
- Related InfoLink provided by the sponsor.
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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.
ahmed mohamed moukhtar, MD principal investigator
professor of anesthesiology cairo university
waleed ibrahim Hamimmy, MD principal investigator
professor of anesthesiology cairo university
akram shahat Eladawy, MD principal investigator
assistant professor of anesthesiology cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragmatic ultrasound in people with Diaphragmatic Ultrasound in Weaning, run by Cairo 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 4 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 1 Oct 2019. 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?
Success rate of weaning from mechanical ventilation in both groups (time frame: 48 Hours after weaning). 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 NCT03608332, which also lists 11 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 1 Oct 2019.