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

NCT ID: NCT06167239

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Guillain-Barre Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Threshold inspiratory muscle trainer

Training of the inspiratory muscles by threshold inspiratory muscle trainer.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

New techniques to train inspiratory muscles in mechanically ventilated patients

Ventilator pressure setting inspiratory muscle training

Training of the inspiratory muscles by ventilator pressure setting.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

New techniques to train inspiratory muscles in mechanically ventilated patients

Traditional treatment

Only prescribed medical treatment programme

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

New techniques to train inspiratory muscles in mechanically ventilated patients

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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El-Sayed Essam

Lecturer at Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elmasry

Role: STUDY_DIRECTOR

Cairo University

Locations

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Kasr Al Ainy School of Medicine

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Elmasry

Role: CONTACT

Phone: 01005587119

Email: [email protected]

Facility Contacts

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School of Medicine

Role: primary

Other Identifiers

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P.T.REC/012/004784

Identifier Type: -

Identifier Source: org_study_id