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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques
  New techniques to train inspiratory muscles in mechanically ventilated patients

Первичные конечные точки

• PH [Срок оценки: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
• PaO2 [Срок оценки: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
• PaCO2 [Срок оценки: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
• HCO3 [Срок оценки: Pre intervention and immediate post intervention, through study completion, an average of two weeks]

Вторичные конечные точки (7)

• Rapid shallow breathing index [Срок оценки: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
• The Horowitz index [Срок оценки: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
• Glasgow coma scale [Срок оценки: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
• Riker Sedation-Agitation Scale [Срок оценки: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
• Respiratory rate [Срок оценки: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
• Minute ventilation [Срок оценки: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
• Weaning success rate [Срок оценки: post intervention at the end of the study, an average of two weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Kasr Al Ainy School of Medicine — Cairo

Идентификаторы

NCT: NCT06167239 · P.T.REC/012/004784

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗