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NCT Number: NCT06167239

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

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Al Ainy School of Medicine

Cairo, Egypt

Location status: Recruiting

Location contact

School of Medicine

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Other

New techniques to train inspiratory muscles in mechanically ventilated patients

Primary outcomes

  1. PH

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

    To measure PH

  2. PaO2

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

    To measure partial pressure of oxygen

  3. PaCO2

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

    To measure partial pressure of carbon dioxide

  4. HCO3

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

    To measure bicarbonate

Secondary outcomes

  1. Rapid shallow breathing index

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

    To measure respiratory endurance

  2. The Horowitz index

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

    To measure PaO2 /FiO2 ratio

  3. Glasgow coma scale

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

    To measure level of consciousness

  4. Riker Sedation-Agitation Scale

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

    Arousal/sedation assessment

  5. Respiratory rate

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

    Number of breath cycles per minute

  6. Minute ventilation

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

    The amount of air that enters the lungs per minute.

  7. Weaning success rate

    Time frame: post intervention at the end of the study, an average of two weeks

    Number of patients weaning from MV

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2023
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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