Diaphragm UltrasoundNCT05063526

The Role of Diaphragmatic Ultrasound as a Predictor of Extubation From Mechanical Ventilation

An observational study of Diaphragm Ultrasound, run by Beni-Suef University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Aim: To evaluate real-time ultrasound in the evaluation of diaphragmatic thickening, thickening fraction and or excursion to predict extubation outcomes. The investigators aimed to compare these parameters with other traditional weaning measures. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diaphragm Ultrasound
What is being tested?: ultrasound
Type of treatment: Medical device
How many people: 120 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2018to 1 Nov 2019
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 65 years
All sexes
Adult, Older adult

Study population: This prospective study was carried out on 40 patients who are mechanically ventilated due to pulmonary disease, 40 patients on mechanical ventilation due to non-pulmonary disease at respiratory ICU and 40Chronic obstructive pulmonary disease (COPD) patients from Outpatient Clinic serving as controls at Embaba Chest Hospital. Cairo, Egypt during a period from January 2018 to November 2019. Written informed consent was obtained from all patients prior to enrollment according to approval at the local committee of Beni-suef University Hospital.

Who may be able to join

Critically ill patients intubated for more than 48 hours who are ready for weaning with the following criteria.
positive end-expiratory pressure (PEEP) ≤ 5 cm H2O.
Fraction of inspired oxygen (FiO2) < 0.5.
respiratory rate (RR) < 30 breaths/min.
rapid shallow breathing index < 105, PaO2/FiO2 > 200.
Age< 65 years.

Who cannot join

Age<18 years.
Patient with history of plural effusion, trauma to chest and history of mechanical ventilation for < 6 months.
patient with neuromuscular diseases affect diaphragm .

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Beni-suef
Banī Suwayf, Mequbal

Other trials in Egypt

About this study

Official title: The Role of Diaphragmatic Ultrasound as a Predictor of Successful Extubation From Mechanical Ventilation in Respiratory Intensive Care Unit

Read the detailed description

The diaphragm is an important respiratory muscle and dysfunction is very common in patients receiving mechanical ventilation. Diaphragm fatigue occurs even in patients who successfully pass the Spontaneous Breathing Test (SBT). Interrupting ventilation too early can lead to increased cardiovascular and respiratory pressure (CO2).retention and hypoxemia with up to 25% of patients requiring reinstitution of ventilator support. Unnecessary delays in liberation from mechanical ventilation also can be deleterious. Complications such as ventilator-associated pneumonia and ventilator-induced diaphragm atrophy can be seen with short periods of mechanical ventilation thereby prolonging mechanical ventilation. As SBT monitoring is insensitive to detect early signs of load-capacity imbalance. The evaluation of the diaphragmatic thickening fraction (DTF) may be also helpful to assess diaphragmatic function and its contribution to respiratory workload. Ultrasound can be used to detect the deflection of the diaphragm, which helps to identify patients with diaphragm dysfunction

Conditions: Diaphragm Ultrasound
Being tested: ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ultrasoundDevice
ultrasound on diaphragm

Study groups in NCT05063526
Study group	Role	What they receive
Group B		40 patients who are mechanically ventilated due to pulmonary disease at respiratory ICU had their diagnosis as follows: 21 (53%) had COPD, 8 (20%) had asthma, 5 (13%) had bronchiectasis, 5 (13%) had pneumonia and 1 (3%) had viral influenza H1N1. Out of group B patients, 11 patients (13.75%) had failed weaning, of which 6 patients needed reintubation and 5 patients needed non-invasive positive ventilation of which 3 patients were re-intubated and 2 patients died. Receives: Device: ultrasound
Group A		40 patients on mechanical ventilation due to non-pulmonary disease at respiratory ICU had their diagnosis as follows: 24 (60%) had congestive heart failure, 4 (10%) had diabetes mellitus, 4 (10%) had sepsis other than pneumonia, 2 (5%) had epilepsy, 2 (5%) had embolic hemiplegia, and 4 (10%) had chronic renal failure. Out of group A patient, 9 patients (11.25%) had failed weaning of which 4 patients needed reintubation and 5 patients needed non-invasive positive ventilation of which 2 patients were reintubated and 3 patients died. Receives: Device: ultrasound
control group.		40 patients Chronic obstructive pulmonary disease (COPD) from Outpatient Clinic Receives: Device: ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

diaphragmatic ultrasound thickening
Right diaphragmatic ultrasound measurement thickening in millimeter was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images
Measured: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
diaphragmatic ultrasound thickening fraction
Right diaphragmatic ultrasound measurement thickening fraction(percentage% ) was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images
Measured: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
diaphragmatic ultrasound excursion
Right diaphragmatic ultrasound measurement excursion( centimeter) was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images
Measured: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year

Secondary outcomes (3)

diaphragmatic ultrasound thickening fraction
Differences in thickening fraction ( millimeter )between patients who are successfully and failed weaning .
Measured: Up to 48 hours on T-tube, through study completion, an average of 1 year
diaphragmatic ultrasound thickening
Differences in diaphragm thickening(percentage% )between patients who are successfully and failed weaning .
Measured: Up to 48 hours on T-tube, through study completion, an average of 1 year
diaphragmatic ultrasound excursion
Differences in diaphragm excursion ( centimeter) between patients who are successfully and failed weaning
Measured: Up to 48 hours on T-tube, through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20181 Nov 2019

First posted1 Oct 2021
Study start1 Jan 2018
Primary completion1 Jan 2018
Study completion1 Nov 2019

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 Diaphragm UltrasoundStudies of the same condition, open and under way.
More trials run by Beni-Suef 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: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05063526
Sponsor's protocol ID: FMBSUREC/05012020/Ahmed
Status last verified: Oct 2021
First submitted: 3 Sep 2021
Last updated: 8 Oct 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ferrari 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
Grosu HB, Lee YI, Lee J, Eden E, Eikermann M, Rose KM. Diaphragm muscle thinning in patients who are mechanically ventilated. Chest. 2012 Dec;142(6):1455-1460. doi: 10.1378/chest.11-1638.
PubMed 23364680
Farghaly 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 27112953
Umbrello M, Formenti P. Ultrasonographic Assessment of Diaphragm Function in Critically Ill Subjects. Respir Care. 2016 Apr;61(4):542-55. doi: 10.4187/respcare.04412. Epub 2016 Jan 26.
PubMed 26814218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diaphragm Ultrasound trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Diaphragmatic Ultrasound as a Predictor of Successful Extubation From Mechanical Ventilation in Respiratory Intensive Care Unit
ClinicalTrials.gov ID: NCT05063526
Acronym / sponsor ID: FMBSUREC/05012020/Ahmed
Conditions: Diaphragm Ultrasound
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Beni-Suef UniversityUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 1 Jan 2018 (actual)
Study completion: 1 Nov 2019 (actual)
First posted: 1 Oct 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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Group B	–	Device: ultrasound40 patients who are mechanically ventilated due to pulmonary disease at respiratory ICU had their diagnosis as follows: 21 (53%) had COPD, 8 (20%) had asthma, 5 (13%) had bronchiectasis, 5 (13%) had pneumonia and 1 (3%) had viral influenza H1N1. Out of group B patients, 11 patients (13.75%) had failed weaning, of which 6 patients needed reintubation and 5 patients needed non-invasive positive ventilation of which 3 patients were re-intubated and 2 patients died.
Group A	–	Device: ultrasound40 patients on mechanical ventilation due to non-pulmonary disease at respiratory ICU had their diagnosis as follows: 24 (60%) had congestive heart failure, 4 (10%) had diabetes mellitus, 4 (10%) had sepsis other than pneumonia, 2 (5%) had epilepsy, 2 (5%) had embolic hemiplegia, and 4 (10%) had chronic renal failure. Out of group A patient, 9 patients (11.25%) had failed weaning of which 4 patients needed reintubation and 5 patients needed non-invasive positive ventilation of which 2 patients were reintubated and 3 patients died.
control group.	–	Device: ultrasound40 patients Chronic obstructive pulmonary disease (COPD) from Outpatient Clinic

Who may qualify

Ages: 18 to 65 years
Sex: All
Age groups: Adult, Older adult
Study population: This prospective study was carried out on 40 patients who are mechanically ventilated due to pulmonary disease, 40 patients on mechanical ventilation due to non-pulmonary disease at respiratory ICU and 40Chronic obstructive pulmonary disease (COPD) patients from Outpatient Clinic serving as controls at Embaba Chest Hospital. Cairo, Egypt during a period from January 2018 to November 2019. Written informed consent was obtained from all patients prior to enrollment according to approval at the local committee of Beni-suef University Hospital.

Key inclusion criteria (6 listed)

Critically ill patients intubated for more than 48 hours who are ready for weaning with the following criteria.
Age< 65 years.

Key exclusion criteria (3 listed)

Age<18 years.
Patient with history of plural effusion, trauma to chest and history of mechanical ventilation for < 6 months.
patient with neuromuscular diseases affect diaphragm .

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
ultrasoundultrasound on diaphragm	Device	Group A, Group B, control group.

Primary outcome

diaphragmatic ultrasound thickening
Time frame: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
Right diaphragmatic ultrasound measurement thickening in millimeter was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images
diaphragmatic ultrasound thickening fraction
Time frame: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
Right diaphragmatic ultrasound measurement thickening fraction(percentage% ) was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images
diaphragmatic ultrasound excursion
Time frame: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year
Right diaphragmatic ultrasound measurement excursion( centimeter) was made during tidal and deep breathing . patient is in the supine position and measurement of right diaphragm by M-mode and B-mode images

3 secondary outcomes

diaphragmatic ultrasound thickening fraction
Time frame: Up to 48 hours on T-tube, through study completion, an average of 1 year
diaphragmatic ultrasound thickening
Time frame: Up to 48 hours on T-tube, through study completion, an average of 1 year
diaphragmatic ultrasound excursion
Time frame: Up to 48 hours on T-tube, through study completion, an average of 1 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 8 Oct 2021.
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 23364680Grosu HB, Lee YI, Lee J, Eden E, Eikermann M, Rose KM. Diaphragm muscle thinning in patients who are mechanically ventilated. Chest. 2012 Dec;142(6):1455-1460. doi: 10.1378/chest.11-1638.
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 26814218Umbrello M, Formenti P. Ultrasonographic Assessment of Diaphragm Function in Critically Ill Subjects. Respir Care. 2016 Apr;61(4):542-55. doi: 10.4187/respcare.04412. Epub 2016 Jan 26.

Related trials for Diaphragm Ultrasound

Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
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Recruiting
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Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
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Recruiting
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Not yet recruitingObservational study
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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.

Randa S Mohamed, professor study director

Benisuef unviresity

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 Diaphragm Ultrasound, run by Beni-Suef 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 6 inclusion and 3 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 8 Oct 2021. 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?

diaphragmatic ultrasound thickening (time frame: during weaning from mechanical ventilation 0n T- tube, through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 NCT05063526, 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 8 Oct 2021.