Mechanical VentilationNCT03314701
Mechanical Ventilation in Multiple Fracture Ribs
A study testing Biphasic Intermittent Positive Airway Pressure (BIPAP) and Airway Pressure Release Ventilation (APRV) in people with Mechanical Ventilation, run by Assiut University at 1 site in Egypt.
Trial summary
Chest trauma is the most common injury in the emergency trauma and rib fractures is the most common trauma in chest trauma. Severe rib fractures can cause paradoxical respiration and mediastinal swing, which has large effects on respiratory and circulatory system, result in acute respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Biphasic Intermittent Positive Airway Pressure (BIPAP) and Airway Pressure Release Ventilation (APRV)
- 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 Oct 2017to Dec 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated chest trauma patient with Multiple fracture ribs patients [ >3 ribs] who will be admitted to the surgical ICU for ventilatory support and will be expected to continue for 2 days or longer
Who cannot join
- Age < 18 years old.
- Pregnant patient.
- Patient who will require fraction of inspired oxygen more than 0.6.
- Air leak from the chest tube.
- Patient with body temperature > 39 Celsius.
- Acute hepatitis or severe liver disease (Child-Pugh class C).
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- Left ventricular ejection fraction less than 30%.
- Heart rate less than 50 beats/min.
- Second or third-degree heart block.
- Systolic pressure < 90 mmHg despite of infusion of 2 vasopressors.
- Patients with known endocrine dysfunction.
- Patient with hypothermia
- Patient on Positive end expiratory pressure more than 14 cmH2o
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Asyut
mohamed abdelatef, MD, 0020882413201, latif_mohamed@hotmail.com
About this study
Official title: Biphasic Intermittent Positive Airway Pressure (BIPAP) Versus Airway Pressure Release Ventilation (APRV) in Patients With Multiple Fracture Ribs
Chest trauma is the most common injury in the emergency trauma and rib fractures is the most common trauma in chest trauma. Severe rib fractures can cause paradoxical respiration and mediastinal swing, which has large effects on respiratory and circulatory system, result in acute respiratory distress syndrome. Mechanical ventilation can significantly improve the hypoxemia of the patients, correct paradoxical respiration, and treat the pulmonary atelectasis
Read the detailed description
To compare between Biphasic Intermittent Positive Airway Pressure (BIPAP) ventilation and Airway Pressure Release Ventilation (APRV) mode in patients with multiple fracture ribs as regard:
- Resting Energy Expenditure
- Oxygenation
- Stability of Physiological Status as cardiovascular activity
- cardiac output
- arterial blood gas measurement including [ blood PH, arterial oxygen tension, arterial carbon dioxide tension, bicarbonate level and base deficit]
- lung and chest compliance
- Length of intensive care unit stay.
- The ICU mortality rate.
- The development of major complications as nosocomial infection (hospital acquired pneumonia and ventilator associated pneumonia), major atelectasis and pneumothorax.
- Conditions
- Mechanical Ventilation
- Being tested
- Biphasic Intermittent Positive Airway Pressure (BIPAP), Airway Pressure Release Ventilation (APRV)
- Keywords
- Resting Energy Expenditure, Multiple Fracture Ribs, Ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic Intermittent Positive Airway Pressure (BIPAP)Device
Following endotracheal intubation BIPAP mode will be started with:
- Inspiratory positive airway pressure [IPAP] at 20 cmH2O
- Expiratory positive airway pressure [EPAP] at 5 cmH2O
- PRESSURE SUPPORT is difference between these two pressures [IPAP]- [EPAP]
- Mandatory pressure will be delivered at rate of 10-12/min. To produce an end tidal carbon dioxide partial pressure in the range of 35-40 mmHg hypercapnia will not be allowed
Airway Pressure Release Ventilation (APRV)Device
- high airway pressure (Phigh) will be set at 20 cmH2O
- low airway pressure ( Plow) will be set at 5 cmH2O
- the release phase setting will be adjusted to terminate the peak expiratory flow rate to ≥ 50%; release frequency of 10-12 cycles/min
- T high at 4.5-6 seconds
- T low at 0.5 to 0.8 second
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Biphasic Intermittent Positive Airway Pressure (BIPAP) group:
Following endotracheal intubation BIPAP mode will be started with:
* Inspiratory positive airway pressure [IPAP] at 20 cmH2O
* Expiratory positive airway pressure [EPAP] at 5 cmH2O
* PRESSURE SUPPORT is difference between these two pressures [IPAP]- [EPAP]
* Mandatory pressure will be delivered at rate of 10-12/min. To produce an end tidal carbon dioxide partial pressure in the range of 35-40 mmHg hypercapnia will not be allowed Receives: Device: Biphasic Intermittent Positive Airway Pressure (BIPAP) |
| Group 2 | Active comparator | Airway Pressure Release Ventilation (APRV) group:
* high airway pressure (Phigh) will be set at 20 cmH2O
* low airway pressure ( Plow) will be set at 5 cmH2O
* the release phase setting will be adjusted to terminate the peak expiratory flow rate to ≥ 50%; release frequency of 10-12 cycles/min
* T high at 4.5-6 seconds
* T low at 0.5 to 0.8 second Receives: Device: Airway Pressure Release Ventilation (APRV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
The total duration of ventilatory support in both groups from randomization to successful weaning (hours)
Measured: within one month
Secondary outcomes (2)
Resting Energy Expenditure
Energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator [CARESCAPE R860]
Measured: within the first 48 hours
Physiological dead space
Physiological dead space will be measured in the two groups after 30 minutes by Volumetric capnography which is included in the metabolic module on General Electric ventilator
Measured: within the first 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start25 Oct 2017
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314701
- Sponsor's protocol ID
- IRB0000879659
- Status last verified
- Jul 2018
- First submitted
- 14 Oct 2017
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biphasic Intermittent Positive Airway Pressure (BIPAP) Versus Airway Pressure Release Ventilation (APRV) in Patients With Multiple Fracture Ribs
- ClinicalTrials.gov ID
- NCT03314701
- Acronym / sponsor ID
- IRB0000879659
- Conditions
- Mechanical Ventilation
- Keywords
- Resting Energy Expenditure, Multiple Fracture Ribs, Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Oct 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.
Chest trauma is the most common injury in the emergency trauma and rib fractures is the most common trauma in chest trauma. Severe rib fractures can cause paradoxical respiration and mediastinal swing, which has large effects on respiratory and circulatory system, result in acute respiratory distress syndrome. Mechanical ventilation can significantly improve the hypoxemia of the patients, correct paradoxical respiration, and treat the pulmonary atelectasis
Detailed description
To compare between Biphasic Intermittent Positive Airway Pressure (BIPAP) ventilation and Airway Pressure Release Ventilation (APRV) mode in patients with multiple fracture ribs as regard:
- Resting Energy Expenditure
- Oxygenation
- Stability of Physiological Status as cardiovascular activity
- cardiac output
- arterial blood gas measurement including [ blood PH, arterial oxygen tension, arterial carbon dioxide tension, bicarbonate level and base deficit]
- lung and chest compliance
- Length of intensive care unit stay.
- The ICU mortality rate.
- The development of major complications as nosocomial infection (hospital acquired pneumonia and ventilator associated pneumonia), major atelectasis and pneumothorax.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Biphasic Intermittent Positive Airway Pressure (BIPAP)Biphasic Intermittent Positive Airway Pressure (BIPAP) group: Following endotracheal intubation BIPAP mode will be started with: * Inspiratory positive airway pressure [IPAP] at 20 cmH2O * Expiratory positive airway pressure [EPAP] at 5 cmH2O * PRESSURE SUPPORT is difference between these two pressures [IPAP]- [EPAP] * Mandatory pressure will be delivered at rate of 10-12/min. To produce an end tidal carbon dioxide partial pressure in the range of 35-40 mmHg hypercapnia will not be allowed |
| Group 2 | Active comparator | Device: Airway Pressure Release Ventilation (APRV)Airway Pressure Release Ventilation (APRV) group: * high airway pressure (Phigh) will be set at 20 cmH2O * low airway pressure ( Plow) will be set at 5 cmH2O * the release phase setting will be adjusted to terminate the peak expiratory flow rate to ≥ 50%; release frequency of 10-12 cycles/min * T high at 4.5-6 seconds * T low at 0.5 to 0.8 second |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Isolated chest trauma patient with Multiple fracture ribs patients [ >3 ribs] who will be admitted to the surgical ICU for ventilatory support and will be expected to continue for 2 days or longer
Key exclusion criteria (13 listed)
- Age < 18 years old.
- Pregnant patient.
- Patient who will require fraction of inspired oxygen more than 0.6.
- Air leak from the chest tube.
- Patient with body temperature > 39 Celsius.
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 |
|---|---|---|
| Biphasic Intermittent Positive Airway Pressure (BIPAP)Following endotracheal intubation BIPAP mode will be started with: * Inspiratory positive airway pressure [IPAP] at 20 cmH2O * Expiratory positive airway pressure [EPAP] at 5 cmH2O * PRESSURE SUPPORT is difference between these two pressures [IPAP]- [EPAP] * Mandatory pressure will be delivered at rate of 10-12/min. To produce an end tidal carbon dioxide partial pressure in the range of 35-40 mmHg hypercapnia will not be allowed | Device | Group 1 |
| Airway Pressure Release Ventilation (APRV)* high airway pressure (Phigh) will be set at 20 cmH2O * low airway pressure ( Plow) will be set at 5 cmH2O * the release phase setting will be adjusted to terminate the peak expiratory flow rate to ≥ 50%; release frequency of 10-12 cycles/min * T high at 4.5-6 seconds * T low at 0.5 to 0.8 second | Device | Group 2 |
Primary outcome
Duration of mechanical ventilation
Time frame: within one month
The total duration of ventilatory support in both groups from randomization to successful weaning (hours)
2 secondary outcomes
Resting Energy Expenditure
Time frame: within the first 48 hours
Physiological dead space
Time frame: within the first 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biphasic Intermittent Positive Airway Pressure (BIPAP) and Airway Pressure Release Ventilation (APRV) in people with Mechanical Ventilation, run by Assiut University 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 1 inclusion and 13 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 9 Jul 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation (time frame: within one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2018.