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Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients

Does Flow Trigger Sensitivity Adjustment Is Translational Mechanisms For Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients?

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06515600
Enrollment
30
Registered
2024-07-23
Start date
2024-08-01
Completion date
2024-10-15
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator-Induced Diaphragmatic Dysfunction

Keywords

Trigger Sensitivity, Diaphragmatic dysfunction, Mechanical Ventilator, Minute Ventilation, Tidal Volume

Brief 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).

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. 1. Laboratory investigations: Arterial blood gases (ABG):- (PH, PCO2, HCO3, and PO2) after the session. 2. 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

Interventions

DEVICEPractice 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.

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking 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

Intervention 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

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

Age (years) Weight (kg) Height (cm) BMI (kg/m²) Inclusion Criteria: * 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%

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
PSAO2 mmHgone weekPSAO2 mmHg
PCO2 mmHgone weekPCO2 mmHg
HCO3 mEQ/Literone weekHCO3 mEQ/Liter
Vital signsone weekHeart Rate (HR) b/min
Respiratory rate RR/minone weekRespiratory rate RR/min
Blood Pressure mmHgone weekBlood Pressure mmHg
Arterial blood gases (ABG):-one weekPH

Secondary

MeasureTime frameDescription
Tidal Volume L/breathone weekTidal Volume L/breath
Ventilator parametersone weekMinute Ventilation L/min

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026