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Completed

NCT Number: NCT02071277

APRV/BIPAP With Spontaneous Breathing on Lung Protection

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).

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Key information

Conditions

Respiratory Insufficiency Lung Diseases Lung Injury Respiration Disorders Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pressure targeted modes

Other

Intervention involving three different pressure-targeted modes (APRV, BIPAP, and BIPAPassist) each in a random order generated by a computer on one ventilator. Each mode will be studied for 20 minutes.

Primary outcomes

  1. Tidal volume in each mode of ventilation

    Time frame: 20 minutes

Secondary outcomes

  1. Inspiratory transpulmonary pressure in each mode of ventilation

    Time frame: 20 minutes

  2. Patient work of breathing

    Time frame: 20 minutes

    Patient work of breathing will be measured by using pressure-time product and pressure generated 100 ms after the onset of an occluded inspiratory effort (P0.1)

  3. The frequency of each breath-type according to the mode

    Time frame: 20 minutes

    Type A: spontaneous breaths occurring during Tlow, Type B: spontaneous breaths occurring during Thigh, Type C: quasi-assisted breaths synchronized with the ventilator cycling to Thigh, Type D: completely passive breaths, Type E: spontaneous breaths occurring as the ventilator cycles to Tlow

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • University of Toronto

Registry information

Official study title

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

Acronym: APRV/BIPAP

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2014
Registry last updated
Apr 19, 2017

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

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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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