Ventilation Therapy; ComplicationsNCT03218943
Physiological Dead Space Measured by Volumetric Capnography in BiPAP and APRV .
A study testing APRV ventilation mode and BIPAP ventilation moood in people with Ventilation Therapy; Complications, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilation Therapy; Complications
- What is being tested?
- APRV ventilation mode and BIPAP ventilation moood
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2017to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults above 18 years old.
- Patients who are recently mechanically ventilated ( within 48 hours ).
- Patients with P/F ratio less than 300.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Department of Anesthesia , intensive care and pain management -faculty of medicine Cairo Uni.- kasr Alainy Hospitals.
Cairo
Ahmed Elkahwagy, 00201008390999, dr.qahwagy@gmail.com
About this study
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.
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.
Read more
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.
Read the 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 .
- Conditions
- Ventilation Therapy; Complications
- Being tested
- APRV ventilation mode, BIPAP ventilation moood
- Keywords
- BiPAP, APRV, Physiological dead space, volumetric capnography, ARDS, impaired oxygenation, ICU, Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APRV ventilation modeDevice
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
BIPAP ventilation mooodDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: APRV ventilation mode |
| 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. Receives: Device: BIPAP ventilation moood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: after 30 min. on each mode ( APRV and BiPAP )
Secondary outcomes (7)
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).
Measured: after 3 hours on each mode ( APRV and BiPAP ).
PO2/FiO2 ratio
PO2 from ABG / FiO2 set on the ventilator
Measured: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
Peak airway pressure
measured by the ventilator in cmH2O.
Measured: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
Mean airway pressure
measured by the ventilator in cmH2O.
Measured: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
Dynamic compliance
measured by the ventilator ml/cmH2O
Measured: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
PCO2
from ABG
Measured: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
pH
from ABG
Measured: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start25 Aug 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventilation Therapy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized controlled study with cross-over design.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samir Awad Elkahwagy, Kasr El Aini Hospital
- Investigators
- Ahmed Elkahwagy, Study director, Department of Anesthesia , intensive care and pain management at kasr Alainy hospitals -faculty of medicine - Cairo Uni. - Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218943
- Sponsor's protocol ID
- N-44-2017
- Status last verified
- Aug 2017
- First submitted
- 11 Jul 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14635498Hormann 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.
PubMed 8143712Baum 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.
PubMed 2686487Verscheure 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.
PubMed 27334879Anderson 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.
PubMed 11094503
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03218943
- Acronym / sponsor ID
- N-44-2017
- Conditions
- Ventilation Therapy; Complications
- Keywords
- BiPAP, APRV, Physiological dead space, volumetric capnography, ARDS, impaired oxygenation, ICU, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 25 Aug 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled study with cross-over design.
| Arm | Type | Receives |
|---|---|---|
| APRV ventilation | Active comparator | Device: APRV ventilation modeThey 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 | Device: BIPAP ventilation mooodThey 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults above 18 years old.
- Patients who are recently mechanically ventilated ( within 48 hours ).
- Patients with P/F ratio less than 300.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APRV ventilation modeThey 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 | Device | APRV ventilation |
| BIPAP ventilation mooodstart 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 | Device | BiPAP ventilation |
Primary outcome
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).
7 secondary outcomes
Physiological dead space.
Time frame: after 3 hours on each mode ( APRV and BiPAP ).
PO2/FiO2 ratio
Time frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
Peak airway pressure
Time frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
Mean airway pressure
Time frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
Dynamic compliance
Time frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
PCO2
Time frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
pH
Time frame: after 30 min. and 3 hours on each mode ( APRV and BiPAP ).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Background: PubMed 14635498Haitsma 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.
- Background: PubMed 8143712Hormann 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.
- Background: PubMed 2686487Baum 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.
- Background: PubMed 27334879Verscheure 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.
- Background: PubMed 11094503Anderson 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elkahwagy study director
Department of Anesthesia , intensive care and pain management at kasr Alainy hospitals -faculty of medicine - Cairo Uni. - Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APRV ventilation mode and BIPAP ventilation moood in people with Ventilation Therapy; Complications, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Elkahwagy (00201008390999, dr.qahwagy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological dead space (time frame: after 30 min. on each mode ( APRV and BiPAP )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218943, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.