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APRV/BIPAP With Spontaneous Breathing on Lung Protection (APRV/BIPAP)

Primary Purpose

Respiratory Insufficiency, Ventilator-Induced Lung Injury

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pressure targeted modes
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Mechanical ventilation, Airway pressure release ventilation, Biphasic intermittent positive airway pressure, Pressure-controlled ventilation, Lung protective ventilation, Spontaneous breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Michael's Hospital
  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pressure targeted modes

Arm Description

Outcomes

Primary Outcome Measures

Tidal volume in each mode of ventilation

Secondary Outcome Measures

Inspiratory transpulmonary pressure in each mode of ventilation
Patient work of breathing
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)
The frequency of each breath-type according to the mode
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

Full Information

First Posted
February 7, 2014
Last Updated
April 18, 2017
Sponsor
Unity Health Toronto
Collaborators
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02071277
Brief Title
APRV/BIPAP With Spontaneous Breathing on Lung Protection
Acronym
APRV/BIPAP
Official Title
Impact of the Type of Pressure Controlled Mode on Lung Protection in Mechanically Ventilated Patients With Spontaneous Breathing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pressure targeted modes
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pressure targeted modes
Intervention Description
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 Outcome Measure Information:
Title
Tidal volume in each mode of ventilation
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Inspiratory transpulmonary pressure in each mode of ventilation
Time Frame
20 minutes
Title
Patient work of breathing
Description
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)
Time Frame
20 minutes
Title
The frequency of each breath-type according to the mode
Description
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
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Brochard, Dr.
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23928898
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. Erratum In: Intensive Care Med. 2013 Dec;39(12):2241. Sferrazza-Papa, G F [corrected to Sferrazza Papa, G F].
Results Reference
background
PubMed Identifier
28986852
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.
Results Reference
derived

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APRV/BIPAP With Spontaneous Breathing on Lung Protection

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