Clinical trial NCT02071277: APRV/BIPAP With Spontaneous Breathing on Lung Protection
Official title: Impact of the Type of Pressure Controlled Mode on Lung Protection in Mechanically Ventilated Patients With Spontaneous Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2014-02-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Tidal volume in each mode of ventilation
timeFrame: 20 minutes
Secondary outcomes:
measure: Inspiratory transpulmonary pressure in each mode of ventilation
timeFrame: 20 minutes
measure: Patient work of breathing
timeFrame: 20 minutes
measure: The frequency of each breath-type according to the mode
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Laurent Brochard, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richard JC, Lyazidi A, Akoumianaki E, Mortaza S, Cordioli RL, Lefebvre JC, Rey N, Piquilloud L, Sferrazza Papa GF, Mercat A, Brochard L. Potentially harmful effects of inspiratory synchronization during pressure preset ventilation. Intensive Care Med. 2013 Nov;39(11):2003-10. doi: 10.1007/s00134-013-3032-7. Epub 2013 Aug 9.
citation: Rittayamai N, Beloncle F, Goligher EC, Chen L, Mancebo J, Richard JM, Brochard L. Effect of inspiratory synchronization during pressure-controlled ventilation on lung distension and inspiratory effort. Ann Intensive Care. 2017 Oct 6;7(1):100. doi: 10.1186/s13613-017-0324-z.