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Trial record 56 of 80731 for:    measured

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

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ClinicalTrials.gov Identifier: NCT03218943
Recruitment Status : Unknown
Verified August 2017 by Ahmed Samir Awad Elkahwagy, Kasr El Aini Hospital.
Recruitment status was:  Recruiting
First Posted : July 17, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Samir Awad Elkahwagy, Kasr El Aini Hospital

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.

Condition or disease Intervention/treatment Phase
Ventilation Therapy; Complications Device: APRV ventilation mode Device: BIPAP ventilation moood Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A randomized controlled study with cross-over design.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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.
Estimated Study Start Date : August 25, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Arm Intervention/treatment
Active Comparator: APRV ventilation
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.
Device: APRV 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

Active Comparator: BiPAP ventilation
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.
Device: BIPAP 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




Primary Outcome Measures :
  1. Physiological dead space [ Time Frame: after 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 Outcome Measures :
  1. Physiological dead space. [ Time Frame: 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).

  2. PO2/FiO2 ratio [ Time Frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ). ]
    PO2 from ABG / FiO2 set on the ventilator

  3. Peak airway pressure [ Time Frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ). ]
    measured by the ventilator in cmH2O.

  4. Mean airway pressure [ Time Frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ). ]
    measured by the ventilator in cmH2O.

  5. Dynamic compliance [ Time Frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ). ]
    measured by the ventilator ml/cmH2O

  6. PCO2 [ Time Frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ). ]
    from ABG

  7. pH [ Time Frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ). ]
    from ABG



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218943


Contacts
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Contact: Ahmed Elkahwagy 00201008390999 dr.qahwagy@gmail.com

Locations
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Egypt
Department of Anesthesia , intensive care and pain management -faculty of medicine Cairo Uni.- kasr Alainy Hospitals. Recruiting
Cairo, Egypt
Contact: Ahmed Elkahwagy    00201008390999    dr.qahwagy@gmail.com   
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Study Director: Ahmed Elkahwagy Department of Anesthesia , intensive care and pain management at kasr Alainy hospitals -faculty of medicine - Cairo Uni. - Egypt

Additional Information:
Publications:
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Responsible Party: Ahmed Samir Awad Elkahwagy, Principal Investigator ,Dr. Ahmed Samir Elkahwagy, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03218943     History of Changes
Other Study ID Numbers: N-44-2017
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ahmed Samir Awad Elkahwagy, Kasr El Aini Hospital:
BiPAP
APRV
Physiological dead space
volumetric capnography
ARDS
impaired oxygenation
ICU
Mechanical ventilation