Clinical trial NCT06515600: Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients
Official title: Does Flow Trigger Sensitivity Adjustment Is Translational Mechanisms For Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventilator-Induced Diaphragmatic Dysfunction
Keywords: Trigger Sensitivity
Diaphragmatic dysfunction
Mechanical Ventilator
Minute Ventilation
Tidal Volume
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Vital signs
timeFrame: one week
measure: Respiratory rate RR/min
timeFrame: one week
measure: Blood Pressure mmHg
timeFrame: one week
measure: Arterial blood gases (ABG):-
timeFrame: one week
measure: PCO2 mmHg
timeFrame: one week
measure: HCO3 mEQ/Liter
timeFrame: one week
measure: PSAO2 mmHg
timeFrame: one week
Secondary outcomes:
measure: Ventilator parameters
timeFrame: one week
measure: Tidal Volume L/breath
timeFrame: one week
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Esteban 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.