APRV/BIPAP With Spontaneous Breathing on Lung Protection

NCT02071277 | Completed

• 1 other identifier: REB 13-362
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Tidal volume in each mode of ventilation

  20 minutes

Secondary Outcomes (3)

• 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 Arms (1)

Pressure targeted modes

EXPERIMENTAL

Other: Pressure targeted modes

Interventions

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.

Pressure targeted modes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• University of Toronto: collaborator

Study Sites (2)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (2)

• 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.

  PMID: 23928898 BACKGROUND

• 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.

  PMID: 28986852 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Injury; Lung Diseases

Study Officials

• Laurent Brochard, Dr.

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 25, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: March 15, 2017
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

CA (2)