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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06167239
Enrollment
45
Registered
2023-12-12
Start date
2023-05-02
Completion date
2024-12-31
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Guillain-Barre Syndrome

Brief 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.

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.

Interventions

OTHERThreshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques

New techniques to train inspiratory muscles in mechanically ventilated patients

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PHPre intervention and immediate post intervention, through study completion, an average of two weeksTo measure PH
PaO2Pre intervention and immediate post intervention, through study completion, an average of two weeksTo measure partial pressure of oxygen
PaCO2Pre intervention and immediate post intervention, through study completion, an average of two weeksTo measure partial pressure of carbon dioxide
HCO3Pre intervention and immediate post intervention, through study completion, an average of two weeksTo measure bicarbonate

Secondary

MeasureTime frameDescription
Respiratory ratePre intervention and immediate post intervention, through study completion, an average of two weeksNumber of breath cycles per minute
Rapid shallow breathing indexPre intervention and immediate post intervention, through study completion, an average of two weeksTo measure respiratory endurance
Weaning success ratepost intervention at the end of the study, an average of two weeksNumber of patients weaning from MV
Minute ventilationPre intervention and immediate post intervention, through study completion, an average of two weeksThe amount of air that enters the lungs per minute.
The Horowitz indexPre intervention and immediate post intervention, through study completion, an average of two weeksTo measure PaO2 /FiO2 ratio
Glasgow coma scalePre intervention and immediate post intervention, through study completion, an average of two weeksTo measure level of consciousness
Riker Sedation-Agitation ScalePre intervention and immediate post intervention, through study completion, an average of two weeksArousal/sedation assessment

Countries

Egypt

Contacts

Primary ContactElmasry
egydodo@rocketmail.com01005587119

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026