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APRV/BIPAP With Spontaneous Breathing on Lung Protection

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02071277
Acronym
APRV/BIPAP
Enrollment
15
Registered
2014-02-25
Start date
2014-03-31
Completion date
2017-03-15
Last updated
2017-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency, Ventilator-Induced Lung Injury

Keywords

Mechanical ventilation, Airway pressure release ventilation, Biphasic intermittent positive airway pressure, Pressure-controlled ventilation, Lung protective ventilation, Spontaneous breathing

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).

Interventions

OTHERPressure targeted modes

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.

Sponsors

University of Toronto
CollaboratorOTHER
Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Tidal volume in each mode of ventilation20 minutes

Secondary

MeasureTime frameDescription
Inspiratory transpulmonary pressure in each mode of ventilation20 minutes
Patient work of breathing20 minutesPatient 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)
The frequency of each breath-type according to the mode20 minutesType 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026