Mechanical VentilationNCT03281785
Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.
A study testing Pressure synchronized intermittent mandatory ventilation and Pressure support mode (PS) in people with Mechanical Ventilation, run by Mansoura University at 1 site in Egypt.
Trial summary
Muscle weakness and dysfunction are common problems in patients hospitalized in the intensive care unit. Respiratory muscle weakness during mechanical ventilation was recognized a state of muscular fatigue. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Pressure synchronized intermittent mandatory ventilation and Pressure support mode (PS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2017to 1 Mar 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 20 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status grades I and II.
- Glasgow coma scale < 8.
- Selections of patients need mechanical ventilation (>2 days).
- Head trauma patients.
Who cannot join
- History of diaphragmatic disease
- Neuromuscular disease
- Anatomical malformation of the diaphragm.
- Patients with chest disease
- Diabetic patients.
- Chest trauma
Show all 11Show fewer
- Chest malignancy.
- Use of non-invasive ventilation before the start of invasive ventilation.
- Selection of patients of short period of mechanical ventilation (< 2 days).
- Hemodynamic instability.
- Morbid obesity (body mass index > 40 kg/m2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Evaluation of the Diaphragmatic Musculature in Mechanically Ventilated Patients in Intensive Care Unit
Muscle weakness and dysfunction are common problems in patients hospitalized in the intensive care unit. Respiratory muscle weakness during mechanical ventilation was recognized a state of muscular fatigue. The terminology 'ventilator-induced diaphragmatic dysfunction' (VIDD) originally was introduced to describe these effects of mechanical ventilation and respiratory muscle unloading on the diaphragm.
Ultrasonography is becoming increasingly popular management of ICU patients. It is a simple, non-invasive and safe imaging technique that can be used for the assessment of distinctive diaphragmatic characteristics.
Parameters such as amplitude and velocity of contraction, which can be assessed using M-mode ultrasound. In addition, static and dynamic (thickening fraction during inspiration) diaphragmatic thickness can also be measured by ultrasonography.
Read the detailed description
The aim of this study is to evaluate the effect of different modes of mechanical ventilation on diaphragmatic thickness using ultrasonography and the relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness in head trauma patients subjected for mechanical ventilation (>2 days) intensive care unit.
Modes of ventilation will be used in the study are:
- Pressure controlled mandatory ventilation mode (P-CMV).
- Pressure synchronized intermittent mandatory ventilation mode (P-SIMV).
- Pressure support (PS) mode.
- Conditions
- Mechanical Ventilation
- Being tested
- Pressure controlled mandatory ventilation mode (P-CMV), Pressure synchronized intermittent mandatory ventilation, Pressure support mode (PS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure controlled mandatory ventilation mode (P-CMV)Other
Pressure controlled mandatory ventilation mode (P-CMV)
Pressure synchronized intermittent mandatory ventilationOther
Pressure synchronized intermittent mandatory ventilation
Pressure support mode (PS)Other
Pressure support mode (PS)
| Study group | Role | What they receive |
|---|---|---|
| Pressure controlled mandatory ventilation mode (P-CMV) | Active comparator | Patients will be ventilated using pressure controlled mandatory ventilation mode Receives: Other: Pressure controlled mandatory ventilation mode (P-CMV) |
| Pressure synchronized intermittent mandatory ventilation | Active comparator | Patients will be ventilated using pressure synchronized intermittent mandatory ventilation mode (P-SIMV) Receives: Other: Pressure synchronized intermittent mandatory ventilation |
| Pressure support mode (PS) | Active comparator | Patents will be ventilated with pressure support mode (PS) Receives: Other: Pressure support mode (PS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic thickness
changes in diaphragmatic thickness from baseline to nadir
Measured: for 3 weeks after initiation of mechanical ventilation
Secondary outcomes (18)
The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness
measurement of the diaphragmatic thickness as usual and calculate the percentage of change of the diaphragmatic thickness over the time of mechanical ventilation
Measured: for 3 weeks after initiation of mechanical ventilation
Glasgow coma scale (GCS)
Measured: for 2 weeks after initiation of mechanical ventilation.
Sequential organ failure assessment (SOFA) score
Measured: for 3 weeks after admission to the ICU
Complete blood picture
Measured: for 3 weeks after admission to the ICU
Coagulation profile
Measured: for 3 weeks after admission to the ICU
Liver function
Measured: for 3 weeks after admission to the ICU
Renal function tests
Measured: for 3 weeks after admission to the ICU
Mean blood pressure
Measured: for 3 weeks after admission to the ICU
Heart rate
Measured: for 3 weeks after admission to the ICU
Arterial Oxygen Saturation
Measured: for 3 weeks after admission to the ICU
Central Venous Pressure
Measured: for 3 weeks after admission to the ICU
temperature
Measured: for 3 weeks after admission to the ICU
mode of ventilation
Measured: for 3 weeks after initiation of mechanical ventilation
tidal volume
Measured: for 3 weeks after initiation of mechanical ventilation
respiratory rate
Measured: for 3 weeks after initiation of mechanical ventilation
airway pressure
peak and mean airway pressure
Measured: for 3 weeks after initiation of mechanical ventilation
ICU stay
Time from admission to the ICU untill discharge or death
Measured: for 3 weeks after initiation of mechanical ventilation
Duration of mechanical ventilation
time from initiation of mechanical ventilation till extubation or death
Measured: for 3 weeks after initiation of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start20 Sep 2017
- Primary completion30 Sep 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amal R Ali, MD, Study chair, Professor of Anesthesia and Surgical Intensive CareHanaa M Elbendary, MD, Study director, Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281785
- Sponsor's protocol ID
- MD%2f16.12.52
- Status last verified
- Mar 2019
- First submitted
- 11 Sep 2017
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of the Diaphragmatic Musculature in Mechanically Ventilated Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03281785
- Acronym / sponsor ID
- MD%2f16.12.52
- Conditions
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 13 Sep 2017 (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.
Muscle weakness and dysfunction are common problems in patients hospitalized in the intensive care unit. Respiratory muscle weakness during mechanical ventilation was recognized a state of muscular fatigue. The terminology 'ventilator-induced diaphragmatic dysfunction' (VIDD) originally was introduced to describe these effects of mechanical ventilation and respiratory muscle unloading on the diaphragm.
Ultrasonography is becoming increasingly popular management of ICU patients. It is a simple, non-invasive and safe imaging technique that can be used for the assessment of distinctive diaphragmatic characteristics.
Parameters such as amplitude and velocity of contraction, which can be assessed using M-mode ultrasound. In addition, static and dynamic (thickening fraction during inspiration) diaphragmatic thickness can also be measured by ultrasonography.
Detailed description
The aim of this study is to evaluate the effect of different modes of mechanical ventilation on diaphragmatic thickness using ultrasonography and the relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness in head trauma patients subjected for mechanical ventilation (>2 days) intensive care unit.
Modes of ventilation will be used in the study are:
- Pressure controlled mandatory ventilation mode (P-CMV).
- Pressure synchronized intermittent mandatory ventilation mode (P-SIMV).
- Pressure support (PS) mode.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pressure controlled mandatory ventilation mode (P-CMV) | Active comparator | Other: Pressure controlled mandatory ventilation mode (P-CMV)Patients will be ventilated using pressure controlled mandatory ventilation mode |
| Pressure synchronized intermittent mandatory ventilation | Active comparator | Other: Pressure synchronized intermittent mandatory ventilationPatients will be ventilated using pressure synchronized intermittent mandatory ventilation mode (P-SIMV) |
| Pressure support mode (PS) | Active comparator | Other: Pressure support mode (PS)Patents will be ventilated with pressure support mode (PS) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status grades I and II.
- Glasgow coma scale < 8.
- Selections of patients need mechanical ventilation (>2 days).
- Head trauma patients.
Key exclusion criteria (11 listed)
- History of diaphragmatic disease
- Neuromuscular disease
- Anatomical malformation of the diaphragm.
- Patients with chest disease
- Diabetic patients.
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 |
|---|---|---|
| Pressure controlled mandatory ventilation mode (P-CMV)Pressure controlled mandatory ventilation mode (P-CMV) | Other | Pressure controlled mandatory ventilation mode (P-CMV) |
| Pressure synchronized intermittent mandatory ventilationPressure synchronized intermittent mandatory ventilation | Other | Pressure synchronized intermittent mandatory ventilation |
| Pressure support mode (PS)Pressure support mode (PS) | Other | Pressure support mode (PS) |
Primary outcome
Diaphragmatic thickness
Time frame: for 3 weeks after initiation of mechanical ventilation
changes in diaphragmatic thickness from baseline to nadir
18 secondary outcomes
The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness
Time frame: for 3 weeks after initiation of mechanical ventilation
Glasgow coma scale (GCS)
Time frame: for 2 weeks after initiation of mechanical ventilation.
Sequential organ failure assessment (SOFA) score
Time frame: for 3 weeks after admission to the ICU
Complete blood picture
Time frame: for 3 weeks after admission to the ICU
Coagulation profile
Time frame: for 3 weeks after admission to the ICU
Liver function
Time frame: for 3 weeks after admission to the ICU
Renal function tests
Time frame: for 3 weeks after admission to the ICU
Mean blood pressure
Time frame: for 3 weeks after admission to the ICU
Heart rate
Time frame: for 3 weeks after admission to the ICU
Arterial Oxygen Saturation
Time frame: for 3 weeks after admission to the ICU
Central Venous Pressure
Time frame: for 3 weeks after admission to the ICU
temperature
Time frame: for 3 weeks after admission to the ICU
mode of ventilation
Time frame: for 3 weeks after initiation of mechanical ventilation
tidal volume
Time frame: for 3 weeks after initiation of mechanical ventilation
respiratory rate
Time frame: for 3 weeks after initiation of mechanical ventilation
airway pressure
Time frame: for 3 weeks after initiation of mechanical ventilation
ICU stay
Time frame: for 3 weeks after initiation of mechanical ventilation
Duration of mechanical ventilation
Time frame: for 3 weeks after initiation of mechanical ventilation
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 28 Mar 2019.
- 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.
Amal R Ali, MD study chair
Professor of Anesthesia and Surgical Intensive Care
Hanaa M Elbendary, MD study director
Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure synchronized intermittent mandatory ventilation and Pressure support mode (PS) in people with Mechanical Ventilation, run by Mansoura 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 4 inclusion and 11 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 28 Mar 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?
Diaphragmatic thickness (time frame: for 3 weeks after initiation of mechanical ventilation). 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 28 Mar 2019.