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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Guillain-Barre Syndrome
• Intervention / Treatment: Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elmasry; Phone Number: 01005587119; Email: egydodo@rocketmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Kasr Al Ainy School of Medicine
    • Contact: School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Threshold inspiratory muscle trainer; Training of the inspiratory muscles by threshold inspiratory muscle trainer.	Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques; New techniques to train inspiratory muscles in mechanically ventilated patients
Experimental: Ventilator pressure setting inspiratory muscle training; Training of the inspiratory muscles by ventilator pressure setting.	Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques; New techniques to train inspiratory muscles in mechanically ventilated patients
No Intervention: Traditional treatment; Only prescribed medical treatment programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PH	To measure PH	Pre intervention and immediate post intervention, through study completion, an average of two weeks
PaO2	To measure partial pressure of oxygen	Pre intervention and immediate post intervention, through study completion, an average of two weeks
PaCO2	To measure partial pressure of carbon dioxide	Pre intervention and immediate post intervention, through study completion, an average of two weeks
HCO3	To measure bicarbonate	Pre intervention and immediate post intervention, through study completion, an average of two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rapid shallow breathing index	To measure respiratory endurance	Pre intervention and immediate post intervention, through study completion, an average of two weeks
The Horowitz index	To measure PaO2 /FiO2 ratio	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Glasgow coma scale	To measure level of consciousness	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Riker Sedation-Agitation Scale	Arousal/sedation assessment	Pre intervention and immediate post intervention, through study completion, an average of two weeks
Respiratory rate	Number of breath cycles per minute	Pre intervention and immediate post intervention, through study completion, an average of two weeks
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
Weaning success rate	Number of patients weaning from MV	post intervention at the end of the study, an average of two weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Elmasry, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: December 9, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Polyradiculoneuropathy; Guillain-Barre Syndrome
• Other Study ID Numbers: P.T.REC/012/004784

Drug and device information, study documents

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