Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients

NCT ID: NCT06515600

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-10-15

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

Conditions

Ventilator-Induced Diaphragmatic Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.

Intervention Type: 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).

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.

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).

Group Type: ACTIVE_COMPARATOR

Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.

Intervention Type: 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).

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Abuzaid

Director, Head of Department of Physiotherapy for Cardiovascular/Respiratory and Geriatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 31346802 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17962636 (View on PubMed)

Other Identifiers

Diaphragm Dysfunction

Identifier Type: -

Identifier Source: org_study_id