Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06515600

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

  • Laboratory investigations: Arterial blood gases (ABG):- (PH, PCO2, HCO3, and PO2) after the session.
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

  • 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.

Primary outcomes

  1. Vital signs

    Time frame: one week

    Heart Rate (HR) b/min

  2. Respiratory rate RR/min

    Time frame: one week

    Respiratory rate RR/min

  3. Blood Pressure mmHg

    Time frame: one week

    Blood Pressure mmHg

  4. Arterial blood gases (ABG):-

    Time frame: one week

    PH

  5. PCO2 mmHg

    Time frame: one week

    PCO2 mmHg

  6. HCO3 mEQ/Liter

    Time frame: one week

    HCO3 mEQ/Liter

  7. PSAO2 mmHg

    Time frame: one week

    PSAO2 mmHg

Secondary outcomes

  1. Ventilator parameters

    Time frame: one week

    Minute Ventilation L/min

  2. Tidal Volume L/breath

    Time frame: one week

    Tidal Volume L/breath

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Does Flow Trigger Sensitivity Adjustment Is Translational Mechanisms For Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients?

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.