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Clinical Trials/NCT02071277
NCT02071277
Completed
N/A

Impact of the Type of Pressure Controlled Mode on Lung Protection in Mechanically Ventilated Patients With Spontaneous Breathing

Unity Health Toronto2 sites in 1 country15 target enrollmentMarch 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Insufficiency
Sponsor
Unity Health Toronto
Enrollment
15
Locations
2
Primary Endpoint
Tidal volume in each mode of ventilation
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Mechanical ventilation (MV) is a cornerstone of management of acute respiratory failure, but MV per se can provoke ventilator-induced lung injury (VILI), especially in acute respiratory distress syndrome (ARDS). Lung protective ventilation strategy has been proved to prevent VILI by using low tidal volume of 6-8 ml/kg of ideal body weight and limiting plateau pressure to less than 30 cmH2O. However, heavy sedation or even paralysis are frequently used to ensure the protective ventilation strategy, both of which are associated with respiratory muscles weakness. Maintaining of spontaneous breathing may decrease the need of sedative drug and improve gas exchange by promoting lung recruitment.

Pressure-targeted mode is the most frequent way of delivering after 48 hours of initiating MV. Three types of pressure-controlled mode are available in intubated patients: Biphasic Intermittent Positive Airway Pressure (BIPAP), Airway Pressure Release Ventilation (APRV), and Pressure-Assist Controlled Ventilation (also called BIPAPassist). They are based on pressure regulation but have the difference in terms of synchronization between the patient and the ventilator. The different working principle of these modes may result in different breathing pattern and consequently different in tidal volume and transpulmonary pressure, which may be potentially harmful. The investigators bench study with a lung model demonstrated higher tidal volume and transpulmonary pressure with the BIPAPassist over APRV despite similar pressure settings and patient's simulated effort. However, the impact of each mode on the delivered tidal volume and the transpulmonary pressure in spontaneously breathing mechanically ventilated patients is currently unknown. Their hypothesis is that when the investigators compare the three pressure-controlled modes, the asynchronous mode (APRV) will result in more protective ventilation strategy over the two other modes (BIPAP and BIPAPassist).

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
March 15, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who admitted in the intensive care unit (ICU) and mechanically ventilated (through an endotracheal or a tracheostomy tube) and meet the following criteria are eligible for study participation:
  • Male or female patient,
  • Age over 18 years,
  • Patient already ventilated with assist controlled mode (volume or pressure) and patient triggering the ventilator,
  • Arterial line indwelling or planning to insert this line,
  • Written informed consent signed and dated by the patient/next of kin after full explanation of the study by the study team and prior to study participation,
  • Patient consent will be requested as soon as the patient will be able to provide informed written consent

Exclusion Criteria

  • Patients who fulfill any of the following exclusion criteria are not eligible for study participation:
  • Hemodynamic instability
  • \> 20% variation of mean arterial pressure and/or heart rate (HR) in the last 2 hours,
  • Need for high dose of vasopressor (higher than 0.2 mcg/kg/min of levophed),
  • High PEEP (\> 12 cmH2O) and/or high fraction of inspired oxygen inspired oxygen fraction (\> 0.6)
  • Severe acidosis (pH ≤ 7.20), or severe alkalosis (pH \> 7.55)
  • Presence of a known esophageal problem, active upper gastrointestinal bleeding or any other contraindication to the insertion of a oro- or naso-gastric tube,
  • Pregnant patient,
  • Presence of intracranial hypertension,
  • Known chronic neuromuscular disease significantly impairing the spontaneous breathing

Outcomes

Primary Outcomes

Tidal volume in each mode of ventilation

Time Frame: 20 minutes

Secondary Outcomes

  • Inspiratory transpulmonary pressure in each mode of ventilation(20 minutes)
  • Patient work of breathing(20 minutes)
  • The frequency of each breath-type according to the mode(20 minutes)

Study Sites (2)

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