Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases

Guillain-Barre Syndrome Clinical Trial

Official title:

Effect of Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases in Mechanically Ventilated Patients, a Randomized Clinical Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167239
• Other study ID #: P.T.REC/012/004784
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: Elmasry
• Phone: 01005587119
• Email: egydodo[@]rocketmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to compare the effect of ventilator trigger sensitivity adjustment versus threshold inspiratory muscle training on arterial blood gases in mechanically ventilated patients.

Description:

Failed extubations are not uncommon in most ICUs, the failure rate ranging from 2 to 20%. Since failed extubation is associated with greater hospital morbidity and mortality and longer length of stay, it is imperative to identify screening techniques that minimize the number of failed extubations.

Many studies have been done on the effect of IMT by threshold IMT and adjustment of mechanical ventilator trigger separately, thereby, it is rational to compare between two methods of training to know which is more effective to help in weaning process through its effect on ABGs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Difficult to wean Guillain barre patients who have been on MV for at least 48 hours. Difficult to wean subjects have been defined as those who fail the first spontaneous breathing trial (SBT)and may require up to 3 SBTs or up to 7 d from the first attempt to achieve successful weaning (B´eduneau G. et al.,2017) and (Annia F. et al.,2019).

2. Age: >18 years.

3. Both sexes will be included.

4. Ventilator mode: Pressure support mode with FiO2= 0.5, positive end expiratory pressure (PEEP) will be<8-10cm/H2Oand respiratory rate < 25.

5. Conscious oriented patient with Glasgow coma score =13.

6. Alertness will be titrated to a Riker Sedation Agitation Score of 4.

7. PH>7.25, arterial oxygen saturation >90%.

8. Cardiovascular stability.

9. Maximal inspiratory pressure from 15 to 30 cm H2O and able to trigger spontaneous breaths on ventilator.

Exclusion Criteria:

1. Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure.

2. Severe breathlessness, when spontaneously breathing.

3. Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training (non-stationary course).

4. Spinal cord injury.

5. Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.

6. Patients on heavy sedation and respiratory muscle paralysis.

7. High peak airway pressure (barotraumas).

8. BMI = 40.

Related Conditions & MeSH terms

• Guillain-Barre Syndrome

Intervention

Other:
• Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques
New techniques to train inspiratory muscles in mechanically ventilated patients

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy School of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PH	To measure PH	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Primary	PaO2	To measure partial pressure of oxygen	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Primary	PaCO2	To measure partial pressure of carbon dioxide	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Primary	HCO3	To measure bicarbonate	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Secondary	Rapid shallow breathing index	To measure respiratory endurance	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Secondary	The Horowitz index	To measure PaO2 /FiO2 ratio	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Secondary	Glasgow coma scale	To measure level of consciousness	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Secondary	Riker Sedation-Agitation Scale	Arousal/sedation assessment	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Secondary	Respiratory rate	Number of breath cycles per minute	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Secondary	Minute ventilation	The amount of air that enters the lungs per minute.	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Secondary	Weaning success rate	Number of patients weaning from MV	post intervention at the end of the study, an average of two weeks