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?

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Ventilator-Induced Diaphragmatic Dysfunction
• Intervention / Treatment: Device: Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; 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.	Device: 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).; 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.
Active Comparator: Controlled group; 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).	Device: 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).; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator parameters	Minute Ventilation L/min	one week
Tidal Volume L/breath	Tidal Volume L/breath	one week

Collaborators and Investigators

• Sponsor: South Valley University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Tidal Volume; Mechanical Ventilator; Diaphragmatic dysfunction; Minute Ventilation; Trigger Sensitivity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: Diaphragm Dysfunction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No