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Background and Rationale :
Mechanical ventilation is an essential component of the care of patients with respiratory failure.Biphasic positive Airway Pressure (BiPAP) and Airway Pressure release ventilation (APRV) are relatively new modes of mechanical ventilation which can be used in treatment of patients with impaired oxygenation.The effect of using BiPAP and APRV modes on reducing the physiological dead space had not been previously investigated. The investigators hypothesize that using APRV mode will decrease physiological dead space more than BiPAP mode in the mechanically ventilated critically ill patients.
Objectives :
To assess the physiological dead space with each mode. To assess lung mechanics during the use of the two modes. To assess the effectiveness of ventilation during the use of the two modes.
Study population & Sample size :
Sixty adult patients more than 18 years old who are mechanically ventilated patients with P/F ratio less than 300. This sample size was calculated based on the assumption that APRV will decrease dead space by 20% with alpha error 0.05 and power 80%. The mean and Standard deviation of the volume of the dead space assessed in a previous study using BIPAP was 40
Study Design :
A randomized controlled non-blinded study with cross-over design. In the Trauma and surgical ICU at 185-Hospital (Kasr Alainy Hospitals).
Methods :
All mechanically ventilated patients in Trauma and surgical ICU at 185-Hospital (Kasr Alainy Hospitals) will start on pressure controlled ventilation mode (PCV) with inspiratory pressure achieving tidal volume 6-8 ml/kg for 2 hours then they will be randomized into one of the two study groups the BIPAP group or the APRV group .
Possible Risk (s) to study population :
By adjusting the ventilator parameters properly and continuous monitoring of the patients in the study, there will be no risk facing the patients.
Outcome parameter (s):
Primary outcome: Physiological dead space will be measured in the two groups after 30 minutes.
Secondary outcomes
All mechanically ventilated patients in Trauma and surgical ICU at 185-Hospital (Kasr Alainy Hospitals) will start on pressure controlled ventilation mode (PCV) with inspiratory pressure achieving tidal volume 6-8 ml/kg for 2 hours then they will be randomized into : A-group (APRV group) & B-group (BiPAP group). which are described later in the 2 arms of the study.
Measurement tools :
The following data will be recorded :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APRV ventilation | Active Comparator | They will start on APRV mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 4:1 for 3 hours Then, they will return to the initial settings ( PCV ) for 2 hours . then, they will be switched into BiPAP mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 1:1 for 3 hours. Then left for ventilation according to the preference of the physician in charge. |
|
| BiPAP ventilation | Active Comparator | They will start on BiPAP mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 1:1 for 3 hours. Then, they will return to the initial settings ( PCV ) for 2 hours . then, they will be switched into APRV mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 4:1 for 3 hours. Then left for ventilation according to the preference of the physician in charge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APRV ventilation mode | Device | They will start on APRV mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 4:1 for 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological dead space | percentage of vd/vt ( dead space volume/ Tidal volume ) which is measured by volumetric capnography included in the metabolic module on General Electric ventilator (Engstrom Carestation, GE Health care, USA). | after 30 min. on each mode ( APRV and BiPAP ) |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological dead space. | percentage of vd/vt ( dead space volume/ Tidal volume ) which is measured by volumetric capnography included in the metabolic module on General Electric ventilator (Engstrom Carestation, GE Health care, USA). | after 3 hours on each mode ( APRV and BiPAP ). |
| PO2/FiO2 ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Elkahwagy | Contact | 00201008390999 | dr.qahwagy@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Elkahwagy | Department of Anesthesia , intensive care and pain management at kasr Alainy hospitals -faculty of medicine - Cairo Uni. - Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia , intensive care and pain management -faculty of medicine Cairo Uni.- kasr Alainy Hospitals. | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14635498 | Background | Haitsma JJ, Lachmann RA, Lachmann B. Lung protective ventilation in ARDS: role of mediators, PEEP and surfactant. Monaldi Arch Chest Dis. 2003 Apr-Jun;59(2):108-18. | |
| 8143712 | Background | Hormann C, Baum M, Putensen C, Mutz NJ, Benzer H. Biphasic positive airway pressure (BIPAP)--a new mode of ventilatory support. Eur J Anaesthesiol. 1994 Jan;11(1):37-42. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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A randomized controlled study with cross-over design.
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| BIPAP ventilation moood | Device | start on BiPAP mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 1:1 for 3 hours |
|
PO2 from ABG / FiO2 set on the ventilator |
| after 30 min. and 3 hours on each mode ( APRV and BiPAP ). |
| Peak airway pressure | measured by the ventilator in cmH2O. | after 30 min. and 3 hours on each mode ( APRV and BiPAP ). |
| Mean airway pressure | measured by the ventilator in cmH2O. | after 30 min. and 3 hours on each mode ( APRV and BiPAP ). |
| Dynamic compliance | measured by the ventilator ml/cmH2O | after 30 min. and 3 hours on each mode ( APRV and BiPAP ). |
| PCO2 | from ABG | after 30 min. and 3 hours on each mode ( APRV and BiPAP ). |
| pH | from ABG | after 30 min. and 3 hours on each mode ( APRV and BiPAP ). |
| 2686487 | Background | Baum M, Benzer H, Putensen C, Koller W, Putz G. [Biphasic positive airway pressure (BIPAP)--a new form of augmented ventilation]. Anaesthesist. 1989 Sep;38(9):452-8. German. |
| 27334879 | Background | Verscheure S, Massion PB, Verschuren F, Damas P, Magder S. Volumetric capnography: lessons from the past and current clinical applications. Crit Care. 2016 Jun 23;20(1):184. doi: 10.1186/s13054-016-1377-3. |
| 11094503 | Background | Anderson CT, Breen PH. Carbon dioxide kinetics and capnography during critical care. Crit Care. 2000;4(4):207-15. doi: 10.1186/cc696. Epub 2000 Jul 12. |
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| D012138 |
| Respiratory Therapy |