Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients

NCT06515600 | Not Yet Recruiting

• 1 other identifier: Diaphragm Dysfunction
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Ventilator-Induced Diaphragmatic Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Ventilator parameters

  one week

• Tidal Volume L/breath

  one week

Study Arms (2)

Study group

EXPERIMENTAL

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.

Controlled group

ACTIVE COMPARATOR

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.

Interventions

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

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Related Publications (2)

• 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.

  PMID: 31346802 RESULT

• 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.

  PMID: 17962636 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Physiotherapy for Cardiovascular/Respiratory and Geriatrics

Model Details: 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

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 23, 2024
• Study Start: August 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 15, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share