Respiratory DiseaseNCT06254417
Study of Diaphragmatic Ultrasound as a Predictor of Mechanical Ventilation in Patients With Respiratory Diseases on Admission to Intensive Care Unit
A study testing Diaphragmatic ultrasound in people with Respiratory Disease, run by Ain Shams University.
Trial summary
Ultrasonography has been used to explore diaphragmatic contractile activity by measuring thickening fraction .When thickening fraction was < 20% during tidal breathing, it is commonly associated with respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Diaphragmatic ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 30 Jul 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dyspnea: respiratory rate > 22 breaths per min.
- Hypoxia: as SO2 < 92% on room air.
- Hypercapnia: as PaCO2 > 45mmHg.
Who cannot join
- Age <18 year.
- Cardiogenic pulmonary edema.
- History of interstitial lung disease (fibrosis).
- Neuromuscular disease.
- Significant chest wall deformities.
- Previous diagnosis of diaphragmatic palsy.
Show all 10Show fewer
- Recent thoracotomy or sternotomy (within the previous year).
- Severe hemodynamic instability or shock.
- Pregnancy.
- Diagnosis of pneumothorax or pneumo mediastinum.
About this study
Ultrasonography has been used to explore diaphragmatic contractile activity by measuring thickening fraction .When thickening fraction was < 20% during tidal breathing, it is commonly associated with respiratory failure.
Diaphragmatic ultrasound had been used before as a tool to predict weaning from mechanical ventilation.
In this study diaphragmatic ultrasound will be done upon admission to predict of mechanical ventilation in patients with respiratory diseases.
Read the detailed description
All Patients will be subjected to the following Detailed history taking from patient or relatives including the cause of respiratory diseases.
Complete physical examination: general and local examination will be carried out for all patients.
All cases undergo standard monitoring including invasive and non-invasive blood pressure monitoring, SpO2 and ECG.
Full laboratory investigations: At the beginning of the study (Arterial blood gases, CBC, Coagulation Profile, Kidney function tests, Liver function tests, Cardiac enzymes).
All patients will be treated according to the international guidelines according to their medical status . As well as Hemodynamic support will be provided by fluids resuscitation and/or catecholamine infusion if necessary, to keep mean arterial pressure >70 mmHg.
Respiratory support will consist of oxygen administration or mechanical ventilation if necessary, to maintain SPO2 > 90% and PH > 7.25.
Diaphragmatic ultrasound will be performed to all patients with respiratory disease to evaluate diaphragmatic thickening and estimate thickening fraction and to evaluate diaphragmatic excursion. Measurements will be obtained at bedside with a portable ultrasound machine equipped with a linear probe (Logic P6 Pro, GE Healthcare). Diaphragmatic thickness measures will be performed on right Intercostal approach through the zone of apposition. Diaphragmatic excursion will be performed using curved-array probe (Logic P6 Pro, GE Healthcare) is positioned below right costal arch at the mid-clavicular line. The ultrasound study will be done and /or supervised by ultrasound expert.
The decision of using mechanical ventilation will not depend on the diaphragmatic ultrasound results.
Primary outcome: estimation of diaphragmatic thickening fraction which will predict mechanical ventilation.
Secondary outcome: estimation of diaphragmatic excursion which will predict mechanical ventilation.
Non invasive ventilation (NIV) will be delivered through a full-face mask connected to a high-performance ventilator. In non-invasive pressure support mode. PEEP and delivered FIO2 will be set to achieve oxygen saturation target of 88-92%. Pressure support level will be adjusted to obtain a target volume of 6-8 mL/kg, a frequency < 30 breaths/min, and air leak < 15%. Cycling will be set at 40% of peak flow. If non-invasive ventilation failed or patient deteriorated invasive ventilation will be required.
Indication of non invasive ventilation:
- Moderate to sever dyspnea increased over usual , respiratory rate more than24 cycle/ min, accessory muscle use and paradoxical breathing.
- Pao2 more than 55 mmHg.
- PH between 7.25 and 7.35.
- Pao2 /Fio2 less than 200.
- Hypoxia So2 less than 88% on O2
Indication of invasive ventilation:
- any contraindication of non invasive ventilation.
- Failure of non invasive ventilation after (1:2) hours.
- Hemodynamic instability. (Decrease base line values >20% on admission)
- Conditions
- Respiratory Disease
- Being tested
- Diaphragmatic ultrasound
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic ultrasoundProcedure or surgery
Diaphragmatic ultrasound will be performed to all patients with respiratory disease to evaluate diaphragmatic thickening and estimate thickening fraction and to evaluate diaphragmatic excursion. Measurements will be obtained at bedside with a portable ultrasound machine equipped with a linear probe (Logic P6 Pro, GE Healthcare). Diaphragmatic thickness measures will be performed on right Intercostal approach through the zone of apposition. Diaphragmatic excursion will be performed using curved-array probe (Logic P6 Pro, GE Healthcare) is positioned below right costal arch at the mid-clavicular line. The ultrasound study will be done and /or supervised by ultrasound expert
| Study group | Role | What they receive |
|---|---|---|
| NON VENTILATED GROUP | Active comparator | Not described Receives: Procedure: Diaphragmatic ultrasound |
| VENTILATED GROUP | Active comparator | Not described Receives: Procedure: Diaphragmatic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimation of diaphragmatic thickening fraction
Measured: immediately after intensive care admission
Secondary outcomes (1)
estimation of diaphragmatic excursion
measurement of the movement of the diaphragm during breathing by ultrasonography(normally about 3-5 centimeter)
Measured: immediately after intensive care admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254417
- Sponsor's protocol ID
- master ICU
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Diaphragmatic Ultrasound as a Predictor of Mechanical Ventilation in Patients With Respiratory Diseases on Admission to Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06254417
- Acronym / sponsor ID
- master ICU
- Conditions
- Respiratory Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 12 Feb 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.
Ultrasonography has been used to explore diaphragmatic contractile activity by measuring thickening fraction .When thickening fraction was < 20% during tidal breathing, it is commonly associated with respiratory failure.
Diaphragmatic ultrasound had been used before as a tool to predict weaning from mechanical ventilation.
In this study diaphragmatic ultrasound will be done upon admission to predict of mechanical ventilation in patients with respiratory diseases.
Detailed description
All Patients will be subjected to the following Detailed history taking from patient or relatives including the cause of respiratory diseases.
Complete physical examination: general and local examination will be carried out for all patients.
All cases undergo standard monitoring including invasive and non-invasive blood pressure monitoring, SpO2 and ECG.
Full laboratory investigations: At the beginning of the study (Arterial blood gases, CBC, Coagulation Profile, Kidney function tests, Liver function tests, Cardiac enzymes).
All patients will be treated according to the international guidelines according to their medical status . As well as Hemodynamic support will be provided by fluids resuscitation and/or catecholamine infusion if necessary, to keep mean arterial pressure >70 mmHg.
Respiratory support will consist of oxygen administration or mechanical ventilation if necessary, to maintain SPO2 > 90% and PH > 7.25.
Diaphragmatic ultrasound will be performed to all patients with respiratory disease to evaluate diaphragmatic thickening and estimate thickening fraction and to evaluate diaphragmatic excursion. Measurements will be obtained at bedside with a portable ultrasound machine equipped with a linear probe (Logic P6 Pro, GE Healthcare). Diaphragmatic thickness measures will be performed on right Intercostal approach through the zone of apposition. Diaphragmatic excursion will be performed using curved-array probe (Logic P6 Pro, GE Healthcare) is positioned below right costal arch at the mid-clavicular line. The ultrasound study will be done and /or supervised by ultrasound expert.
The decision of using mechanical ventilation will not depend on the diaphragmatic ultrasound results.
Primary outcome: estimation of diaphragmatic thickening fraction which will predict mechanical ventilation.
Secondary outcome: estimation of diaphragmatic excursion which will predict mechanical ventilation.
Non invasive ventilation (NIV) will be delivered through a full-face mask connected to a high-performance ventilator. In non-invasive pressure support mode. PEEP and delivered FIO2 will be set to achieve oxygen saturation target of 88-92%. Pressure support level will be adjusted to obtain a target volume of 6-8 mL/kg, a frequency < 30 breaths/min, and air leak < 15%. Cycling will be set at 40% of peak flow. If non-invasive ventilation failed or patient deteriorated invasive ventilation will be required.
Indication of non invasive ventilation:
- Moderate to sever dyspnea increased over usual , respiratory rate more than24 cycle/ min, accessory muscle use and paradoxical breathing.
- Pao2 more than 55 mmHg.
- PH between 7.25 and 7.35.
- Pao2 /Fio2 less than 200.
- Hypoxia So2 less than 88% on O2
Indication of invasive ventilation:
- any contraindication of non invasive ventilation.
- Failure of non invasive ventilation after (1:2) hours.
- Hemodynamic instability. (Decrease base line values >20% on admission)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NON VENTILATED GROUP | Active comparator | Procedure: Diaphragmatic ultrasound |
| VENTILATED GROUP | Active comparator | Procedure: Diaphragmatic ultrasound |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dyspnea: respiratory rate > 22 breaths per min.
- Hypoxia: as SO2 < 92% on room air.
- Hypercapnia: as PaCO2 > 45mmHg.
Key exclusion criteria (10 listed)
- Age <18 year.
- Cardiogenic pulmonary edema.
- History of interstitial lung disease (fibrosis).
- Neuromuscular disease.
- Significant chest wall deformities.
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 ultrasound will be performed to all patients with respiratory disease to evaluate diaphragmatic thickening and estimate thickening fraction and to evaluate diaphragmatic excursion. Measurements will be obtained at bedside with a portable ultrasound machine equipped with a linear probe (Logic P6 Pro, GE Healthcare). Diaphragmatic thickness measures will be performed on right Intercostal approach through the zone of apposition. Diaphragmatic excursion will be performed using curved-array probe (Logic P6 Pro, GE Healthcare) is positioned below right costal arch at the mid-clavicular line. The ultrasound study will be done and /or supervised by ultrasound expert | Procedure or surgery | NON VENTILATED GROUP, VENTILATED GROUP |
Primary outcome
estimation of diaphragmatic thickening fraction
Time frame: immediately after intensive care admission
1 secondary outcome
estimation of diaphragmatic excursion
Time frame: immediately after intensive care admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
Related trials for Respiratory Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic ultrasound in people with Respiratory Disease, run by Ain Shams University.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
estimation of diaphragmatic thickening fraction (time frame: immediately after intensive care admission). 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 12 Feb 2024.