Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients

Not Applicable

Not yet recruiting

• Conditions: Ventilator-Induced Diaphragmatic Dysfunction

• Registration Number: NCT06515600
• Lead Sponsor: South Valley University

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

Study Timeline

• Study First Submitted: 2024-06-19
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Study Start: 2024-08-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HCO3 mEQ/Liter	one week	HCO3 mEQ/Liter
Arterial blood gases (ABG):-	one week	PH
PCO2 mmHg	one week	PCO2 mmHg
PSAO2 mmHg	one week	PSAO2 mmHg
Vital signs	one week	Heart Rate (HR) b/min
Respiratory rate RR/min	one week	Respiratory rate RR/min
Blood Pressure mmHg	one week	Blood Pressure mmHg

Secondary Outcome Measures

Name	Time	Method
Tidal Volume L/breath	one week	Tidal Volume L/breath
Ventilator parameters	one week	Minute Ventilation L/min