APRV/BIPAP With Spontaneous Breathing on Lung Protection

NCT ID: NCT02071277

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-03-15

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).

Conditions

Respiratory Insufficiency; Ventilator-Induced Lung Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pressure targeted modes

Group Type: EXPERIMENTAL

Pressure targeted modes

Intervention Type: 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.

Interventions

Pressure 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Brochard, Dr.

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 23928898 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28986852 (View on PubMed)

Other Identifiers

REB 13-362

Identifier Type: -

Identifier Source: org_study_id