Ventilator-Induced Diaphragmatic DysfunctionNCT06515600
Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients
A study testing Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment. in people with Ventilator-Induced Diaphragmatic Dysfunction, run by South Valley University.
Trial summary
The study is a prospective experimental study on adult patients admitted to the Critical Care Department in Qasr Al-Ainy. This study is conducted prospectively to assess the efficiency of trigger sensitivity adjustment on patients with ventilator-induced diaphragmatic dysfunction (VIDD). Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilator-Induced Diaphragmatic Dysfunction
- What is being tested?
- Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 15 Oct 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who had undergone MV for 48 hours or more in a controlled mode.
- Patients could not generate maximum inspiratory pressure of more than 15 mbar
- Patients had diaphragmatic excursion less than 3 cm. (normal level from 3 to 5 cm.)(It can increase in a condition person to 7-8 cm).
- Patients had a diaphragmatic thickness fraction of less than 30%
Who cannot join
- Patients with comorbidities interfering and compromising weaning like cardiac arrhythmia, pericardial effusion, congestive heart failure, or unstable acute coronary syndrome.
- Patients who had inadequate training performance of the inspiratory muscle such as those having myopathy or neuropathy.
- Patients hemodynamically unstable.
- Patients who had a major neurological deficit.
- Sedated Patients.
About this study
Official title: Does Flow Trigger Sensitivity Adjustment Is Translational Mechanisms For Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients?
The study is a prospective experimental study on adult patients admitted to the Critical Care Department in Qasr Al-Ainy. This study is conducted prospectively to assess the efficiency of trigger sensitivity adjustment on patients with ventilator-induced diaphragmatic dysfunction (VIDD).
Read the detailed description
The study is a prospective experimental study on adult patients admitted to the Critical Care Department in Qasr Al-Ainy. This study is conducted prospectively to assess the efficiency of trigger sensitivity adjustment on patients with ventilator-induced diaphragmatic dysfunction (VIDD).1. Flow Trigger: This type of trigger responds to the gas flow during inspiration. A flow trigger measures the rate of change of flow as the patient begins to inhale. When the flow reaches a certain threshold, the ventilator is triggered to deliver a breath.
- Laboratory investigations: Arterial blood gases (ABG):- (PH, PCO2, HCO3, and PO2) after the session.
- Ventilator Parameters:( a) Minute Ventilation, b) Tidal Volume, c) Rapid Shallow breathing index, d) Negative Inspiratory Force (NIF) will be measured pre and post-treatment
- Being tested
- Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.
- Keywords
- Trigger Sensitivity, Diaphragmatic dysfunction, Mechanical Ventilator, Minute Ventilation, Tidal Volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.Device
All patients were investigated by routine investigation (vital signs, arterial blood gas, ventilator mode, and the parameters).
Two sessions were implemented per day for the study group for one week. The Trigger sensitivity adjustment trial begins with applying a load of 30% of the first recorded Negative Inspiratory Force (NIF).
- st Day 1st session, 30% 5 min.
- nd session, 30% 10 min.
2nd Day 1st session, 30% 15 min 2nd session, 30% 20 min.
3rd Day 1st session, 30% 25 min. 2nd session, 30% 30 min.
4th Day 1st session, 40% 5 min. 2nd session, 40% 10 min.
5th Day 1st session 40% 15 min 2nd session 40% 20 min.
6th Day 1st session 40% 25 min. 2nd session 40% 30 min.
7th Day 1st session 50% 5 min. 2nd session 50% 10 min.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Group (A) (study group) will include 30 patients who practiced flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment. Receives: Device: Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment. |
| Controlled group | Active comparator | Group (B) (controlled group) will include 30 patients who received their routine plan of weaning of mechanical ventilator (controlled mode then spontaneous mode and finally spontaneous breathing trial). Receives: Device: Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs
Heart Rate (HR) b/min
Measured: one week
Respiratory rate RR/min
Respiratory rate RR/min
Measured: one week
Blood Pressure mmHg
Blood Pressure mmHg
Measured: one week
Arterial blood gases (ABG):-
PH
Measured: one week
PCO2 mmHg
PCO2 mmHg
Measured: one week
HCO3 mEQ/Liter
HCO3 mEQ/Liter
Measured: one week
PSAO2 mmHg
PSAO2 mmHg
Measured: one week
Secondary outcomes (2)
Ventilator parameters
Minute Ventilation L/min
Measured: one week
Tidal Volume L/breath
Tidal Volume L/breath
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator-Induced Diaphragmatic DysfunctionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our Study was performed on sixty patients with VIDD from both genders. All patients will be referred by a physician. All patients were randomly assigned into two groups equal in number
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Abuzaid, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515600
- Sponsor's protocol ID
- Diaphragm Dysfunction
- Status last verified
- Jul 2024
- First submitted
- 19 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After publication
Publications
Penuelas O, Keough E, Lopez-Rodriguez L, Carriedo D, Goncalves G, Barreiro E, Lorente JA. Ventilator-induced diaphragm dysfunction: translational mechanisms lead to therapeutical alternatives in the critically ill. Intensive Care Med Exp. 2019 Jul 25;7(Suppl 1):48. doi: 10.1186/s40635-019-0259-9.
PubMed 31346802Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.
PubMed 17962636
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Flow Trigger Sensitivity Adjustment Is Translational Mechanisms For Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients?
- ClinicalTrials.gov ID
- NCT06515600
- Acronym / sponsor ID
- Diaphragm Dysfunction
- Keywords
- Trigger Sensitivity, Diaphragmatic dysfunction, Mechanical Ventilator, Minute Ventilation, Tidal Volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 23 Jul 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.
The study is a prospective experimental study on adult patients admitted to the Critical Care Department in Qasr Al-Ainy. This study is conducted prospectively to assess the efficiency of trigger sensitivity adjustment on patients with ventilator-induced diaphragmatic dysfunction (VIDD).
Detailed description
The study is a prospective experimental study on adult patients admitted to the Critical Care Department in Qasr Al-Ainy. This study is conducted prospectively to assess the efficiency of trigger sensitivity adjustment on patients with ventilator-induced diaphragmatic dysfunction (VIDD).1. Flow Trigger: This type of trigger responds to the gas flow during inspiration. A flow trigger measures the rate of change of flow as the patient begins to inhale. When the flow reaches a certain threshold, the ventilator is triggered to deliver a breath.
- Laboratory investigations: Arterial blood gases (ABG):- (PH, PCO2, HCO3, and PO2) after the session.
- Ventilator Parameters:( a) Minute Ventilation, b) Tidal Volume, c) Rapid Shallow breathing index, d) Negative Inspiratory Force (NIF) will be measured pre and post-treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Our Study was performed on sixty patients with VIDD from both genders. All patients will be referred by a physician. All patients were randomly assigned into two groups equal in number
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.Group (A) (study group) will include 30 patients who practiced flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment. |
| Controlled group | Active comparator | Device: Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.Group (B) (controlled group) will include 30 patients who received their routine plan of weaning of mechanical ventilator (controlled mode then spontaneous mode and finally spontaneous breathing trial). |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who had undergone MV for 48 hours or more in a controlled mode.
- Patients could not generate maximum inspiratory pressure of more than 15 mbar
- Patients had diaphragmatic excursion less than 3 cm. (normal level from 3 to 5 cm.)(It can increase in a condition person to 7-8 cm).
- Patients had a diaphragmatic thickness fraction of less than 30%
Key exclusion criteria (5 listed)
- Patients with comorbidities interfering and compromising weaning like cardiac arrhythmia, pericardial effusion, congestive heart failure, or unstable acute coronary syndrome.
- Patients who had inadequate training performance of the inspiratory muscle such as those having myopathy or neuropathy.
- Patients hemodynamically unstable.
- Patients who had a major neurological deficit.
- Sedated 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 |
|---|---|---|
| Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.All patients were investigated by routine investigation (vital signs, arterial blood gas, ventilator mode, and the parameters). Two sessions were implemented per day for the study group for one week. The Trigger sensitivity adjustment trial begins with applying a load of 30% of the first recorded Negative Inspiratory Force (NIF). 1. st Day 1st session, 30% 5 min. 2. nd session, 30% 10 min. 2nd Day 1st session, 30% 15 min 2nd session, 30% 20 min. 3rd Day 1st session, 30% 25 min. 2nd session, 30% 30 min. 4th Day 1st session, 40% 5 min. 2nd session, 40% 10 min. 5th Day 1st session 40% 15 min 2nd session 40% 20 min. 6th Day 1st session 40% 25 min. 2nd session 40% 30 min. 7th Day 1st session 50% 5 min. 2nd session 50% 10 min. | Device | Controlled group, Study group |
Primary outcome
Vital signs
Time frame: one week
Heart Rate (HR) b/min
Respiratory rate RR/min
Time frame: one week
Respiratory rate RR/min
Blood Pressure mmHg
Time frame: one week
Blood Pressure mmHg
Arterial blood gases (ABG):-
Time frame: one week
PH
PCO2 mmHg
Time frame: one week
PCO2 mmHg
HCO3 mEQ/Liter
Time frame: one week
HCO3 mEQ/Liter
PSAO2 mmHg
Time frame: one week
PSAO2 mmHg
2 secondary outcomes
Ventilator parameters
Time frame: one week
Tidal Volume L/breath
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Results publication: PubMed 31346802Penuelas O, Keough E, Lopez-Rodriguez L, Carriedo D, Goncalves G, Barreiro E, Lorente JA. Ventilator-induced diaphragm dysfunction: translational mechanisms lead to therapeutical alternatives in the critically ill. Intensive Care Med Exp. 2019 Jul 25;7(Suppl 1):48. doi: 10.1186/s40635-019-0259-9.
- Results publication: PubMed 17962636Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.
- Individual participant dataSharing planned: No. After publication
Related trials for Ventilator-Induced Diaphragmatic Dysfunction
Not yet recruitingObservational study
Nutritional Risk and Diaphragmatic Thickness in Mechanically Ventilated COPD Patients
Chronic Obstructive Pulmonary Disease (COPD), Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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 Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment. in people with Ventilator-Induced Diaphragmatic Dysfunction, run by South Valley 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 4 inclusion and 5 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 23 Jul 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?
Vital signs (time frame: one week). The study lists 7 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 NCT06515600, which also lists 2 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 23 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.