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

NCT06167239 | Recruiting

• 1 other identifier: P.T.REC/012/004784
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Guillain-Barre Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Rapid shallow breathing index

  Pre intervention and immediate post intervention, through study completion, an average of two weeks

• The Horowitz index

  Pre intervention and immediate post intervention, through study completion, an average of two weeks

• Glasgow coma scale

  Pre intervention and immediate post intervention, through study completion, an average of two weeks

• Riker Sedation-Agitation Scale

  Pre intervention and immediate post intervention, through study completion, an average of two weeks

• Respiratory rate

  Pre intervention and immediate post intervention, through study completion, an average of two weeks

Study Arms (3)

Threshold inspiratory muscle trainer

EXPERIMENTAL

Training of the inspiratory muscles by threshold inspiratory muscle trainer.

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

Ventilator pressure setting inspiratory muscle training

EXPERIMENTAL

Training of the inspiratory muscles by ventilator pressure setting.

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

Traditional treatment

NO INTERVENTION

Only prescribed medical treatment programme

Interventions

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

New techniques to train inspiratory muscles in mechanically ventilated patients

Threshold inspiratory muscle trainer; Ventilator pressure setting inspiratory muscle training

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Age: \>18 years.
• Both sexes will be included.
• Ventilator mode: Pressure support mode with FiO2≤ 0.5, positive end expiratory pressure (PEEP) will be\<8-10cm/H2Oand respiratory rate \< 25.
• Conscious oriented patient with Glasgow coma score ≥13.
• Alertness will be titrated to a Riker Sedation Agitation Score of 4.
• PH\>7.25, arterial oxygen saturation \>90%.
• Cardiovascular stability.
• Maximal inspiratory pressure from 15 to 30 cm H2O and able to trigger spontaneous breaths on ventilator.

You may not qualify if:

• Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure.
• Severe breathlessness, when spontaneously breathing.
• Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training (non-stationary course).
• Spinal cord injury.
• Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.
• Patients on heavy sedation and respiratory muscle paralysis.
• High peak airway pressure (barotraumas).
• BMI ≥ 40.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al Ainy School of Medicine

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elmasry

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Elmasry

CONTACT

01005587119; egydodo@rocketmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: December 12, 2023
• Study Start: May 2, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

EG (1)