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Physiological Dead Space Measured by Volumetric Capnography in BiPAP and APRV .

Physiological Dead Space Measured by Volumetric Capnography, Is it Different Between the Biphasic Positive Airway Pressure Mode ( BiPAP ) and Airway Pressure Release Ventilation Mode ( APRV ) ? A Randomized Controlled Study.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03218943
Enrollment
60
Registered
2017-07-17
Start date
2017-08-25
Completion date
2017-09-30
Last updated
2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation Therapy; Complications

Keywords

BiPAP, APRV, Physiological dead space, volumetric capnography, ARDS, impaired oxygenation, ICU, Mechanical ventilation

Brief summary

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 * Physiological dead space after 3 hours. * PO2/FiO2 ratio. * Peak airway and Mean airway pressures. * PCO2 and PH. * Dynamic compliance.

Detailed description

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 : * Demographic data ( Age , Sex , Weight and Height ). * P/F ratio before inclusion. * All patients then will be connected to Volumetric capnography which is included in the metabolic module on General Electric ventilator (Engstrom Carestation, GE Health care, USA). and physiological dead space will be recorded after 30 minutes and at the end of the 3 hours on each APRV & BiPAP modes . * Peak air way pressure. * Mean airway Pressure. They will be also recorded after * Dynamic Compliance. 30 Minutes and at the end of the * P/F ratio , PH and pCO2. 3 hours On APRV & BiPAP modes. * Minute ventilation. * Blood pressure , Heart rate and central venous pressure will be recorded before inclusion . then , they will be also recorded every 2 hours .

Interventions

DEVICEAPRV ventilation mode

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

DEVICEBIPAP ventilation moood

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

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

A randomized controlled study with cross-over design.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults above 18 years old. * Patients who are recently mechanically ventilated ( within 48 hours ). * Patients with P/F ratio less than 300.

Exclusion criteria

* patients with COPD or pneumothorax. * Patients with acute lung injury. * patients with Emphysema and Emphysematous bullae . * patients with broncho-pleural fistula. * patients with severe hemodynamic instability (on IV Noradrenaline \> 0.8 mic/kg/min). * patients with cardiomyopathy , and those with stenotic valvular diseases. * Patients with increased intracerebral pressure.

Design outcomes

Primary

MeasureTime frameDescription
Physiological dead spaceafter 30 min. on each mode ( APRV and BiPAP )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).

Secondary

MeasureTime frameDescription
pHafter 30 min. and 3 hours on each mode ( APRV and BiPAP ).from ABG
Physiological dead space.after 3 hours on each mode ( APRV and BiPAP ).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).
PO2/FiO2 ratioafter 30 min. and 3 hours on each mode ( APRV and BiPAP ).PO2 from ABG / FiO2 set on the ventilator
PCO2after 30 min. and 3 hours on each mode ( APRV and BiPAP ).from ABG
Mean airway pressureafter 30 min. and 3 hours on each mode ( APRV and BiPAP ).measured by the ventilator in cmH2O.
Dynamic complianceafter 30 min. and 3 hours on each mode ( APRV and BiPAP ).measured by the ventilator ml/cmH2O
Peak airway pressureafter 30 min. and 3 hours on each mode ( APRV and BiPAP ).measured by the ventilator in cmH2O.

Countries

Egypt

Contacts

Primary ContactAhmed Elkahwagy
dr.qahwagy@gmail.com00201008390999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026