Mechanical VentilationNCT04205422
Effect of Two Modes of Mechanical Ventilation on Metabolic Demands and Respiratory Mechanics
A study testing BIPAP and APRV in people with Mechanical Ventilation, run by Assiut University.
Trial summary
Adequate supply of energy is an essential part of the overall treatment of critically ill patients and adjustment of energy requirements of patients is important clinical evolution .The adequate assessment of energy expenditure is the basis of effective nutri¬tional planning. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- BIPAP and APRV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jun 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Critically ill trauma patients need mechanical ventilation
Who cannot join
- Pregnant patient.
- Air leak from the chest tube.
- Patient with body temperature > 39 Celsius.
- Acute hepatitis or severe liver disease (Child-Pugh class C).
- Left ventricular ejection fraction less than 30%.
- Heart rate less than 50 beats/min.
Show all 11Show fewer
- 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
About this study
Official title: Biphasic Intermittent Positive Airway Pressure Versus Airway Pressure Release Ventilation in Critically Ill Trauma Patients: Metabolic Demands and Respiratory Mechanics
Adequate supply of energy is an essential part of the overall treatment of critically ill patients and adjustment of energy requirements of patients is important clinical evolution .The adequate assessment of energy expenditure is the basis of effective nutri¬tional planning.
Read the detailed description
Inappropriate energy supply, may cause important complications that affect the progression of the disease, especially in critically ill patients receiving mechanical ventilation. Mechanically ventilated patients make a considerable respiratory muscle effort that is not always decreased by intermittent positive pressure ventilation.
No work of breathing is observed in patients under controlled mechanical ventilation who are receiving drugs for sedation and muscle paralysis. In this situation, the work of breathing is carried out by the ventilator which initiates the ventilation cycle, and patients are spared the inspiratory efforts. Conversely, in assisted ventilation modes, the patient has to make a considerable inspiratory effort before a ventilation cycle initiates, and there is no airflow up to the moment when the effective sensitivity threshold is reached by the ventilator. Therefore, the choice of ventilation mode may determine differences in energy expenditure.
Some studies found that in patients on mechanical ventilation, weight, height, body temperature, type of mechanical ventilation, and type of medication received influenced the REE Acute hypoxemic respiratory failure is a common reason for patients to be admitted to the intensive care unit (ICU). An international study showed an incidence of acute respiratory distress syndrome (ARDS) of 10.4% in ICU critically ill trauma patients with an hospital mortality reaching 46.1% for most severe cases. A protective ventilation strategy using low tidal vol-ume (LTV) and a plateau pressure lower than 30 cmH2O is widely accepted to limit ventilator-induced lung injury, and it currently represents the intervention able to reduce mortality supported by the strongest evidences. Airway pressure release ventilation (APRV) was described for the first time by Stock and Downs and consists in a time-triggered, pressure-limited and time-cycled ventilation mode in which the pressure was alternated from a high level (Phigh) applied for a prolonged time (Thigh) to maintain adequate lung volume and alveo-lar recruitment, to a low level (Plow) for a short period of time (Tlow) where most of ventilation and CO2 removal occurs. In contrast to pressure-controlled inverse-ratio ventilation, APRV uses a release valve that allows spontaneous breathing during any phase of respiratory cycle. The rationale behind this approach is to maintain a pressure above the closing pressure of recruitable alveoli for a sustained time, limiting the release time to allow CO2 removal but avoiding de-recruitment. Another conceptual advantage to APRV over controlled modes is the preservation of spontaneous breathing, which may pro-mote a redistribution of aeration to the dependent lung regions, less need for neuromuscular blockade and sedation, improved venous return and a better ventilation/perfusion (V/Q) matching. For this reason, APRV has been considered a tempting mode of ventilation during acute respiratory failure within the concept of open lung ventilation.
- Conditions
- Mechanical Ventilation
- Being tested
- BIPAP, APRV
- Keywords
- metabolic requirements, respiratory mechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIPAPProcedure or surgery
Biphasic Intermittent Positive Airway Pressure
APRVProcedure or surgery
Airway Pressure Release Ventilation
| Study group | Role | What they receive |
|---|---|---|
| BIPAP group | Active comparator | Biphasic Intermittent Positive Airway Pressure group Receives: Procedure: BIPAP |
| APRV group | Active comparator | Airway Pressure Release Ventilation group: Receives: Procedure: APRV |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy expenditure
energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator
Measured: 48 hours after enrollment
Secondary outcomes (3)
arterial oxygen tension
measured from arterial sample
Measured: 48 hours after enrollment
arterial carbon dioxide tension
measured from arterial sample
Measured: 48 hours after enrollment
arterial pH
measured from arterial sample
Measured: 48 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jun 2022 (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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelbaky Abdelrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205422
- Sponsor's protocol ID
- Anesthesia 25
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biphasic Intermittent Positive Airway Pressure Versus Airway Pressure Release Ventilation in Critically Ill Trauma Patients: Metabolic Demands and Respiratory Mechanics
- ClinicalTrials.gov ID
- NCT04205422
- Acronym / sponsor ID
- Anesthesia 25
- Conditions
- Mechanical Ventilation
- Keywords
- metabolic requirements, respiratory mechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 19 Dec 2019 (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.
Adequate supply of energy is an essential part of the overall treatment of critically ill patients and adjustment of energy requirements of patients is important clinical evolution .The adequate assessment of energy expenditure is the basis of effective nutri¬tional planning.
Detailed description
Inappropriate energy supply, may cause important complications that affect the progression of the disease, especially in critically ill patients receiving mechanical ventilation. Mechanically ventilated patients make a considerable respiratory muscle effort that is not always decreased by intermittent positive pressure ventilation.
No work of breathing is observed in patients under controlled mechanical ventilation who are receiving drugs for sedation and muscle paralysis. In this situation, the work of breathing is carried out by the ventilator which initiates the ventilation cycle, and patients are spared the inspiratory efforts. Conversely, in assisted ventilation modes, the patient has to make a considerable inspiratory effort before a ventilation cycle initiates, and there is no airflow up to the moment when the effective sensitivity threshold is reached by the ventilator. Therefore, the choice of ventilation mode may determine differences in energy expenditure.
Some studies found that in patients on mechanical ventilation, weight, height, body temperature, type of mechanical ventilation, and type of medication received influenced the REE Acute hypoxemic respiratory failure is a common reason for patients to be admitted to the intensive care unit (ICU). An international study showed an incidence of acute respiratory distress syndrome (ARDS) of 10.4% in ICU critically ill trauma patients with an hospital mortality reaching 46.1% for most severe cases. A protective ventilation strategy using low tidal vol-ume (LTV) and a plateau pressure lower than 30 cmH2O is widely accepted to limit ventilator-induced lung injury, and it currently represents the intervention able to reduce mortality supported by the strongest evidences. Airway pressure release ventilation (APRV) was described for the first time by Stock and Downs and consists in a time-triggered, pressure-limited and time-cycled ventilation mode in which the pressure was alternated from a high level (Phigh) applied for a prolonged time (Thigh) to maintain adequate lung volume and alveo-lar recruitment, to a low level (Plow) for a short period of time (Tlow) where most of ventilation and CO2 removal occurs. In contrast to pressure-controlled inverse-ratio ventilation, APRV uses a release valve that allows spontaneous breathing during any phase of respiratory cycle. The rationale behind this approach is to maintain a pressure above the closing pressure of recruitable alveoli for a sustained time, limiting the release time to allow CO2 removal but avoiding de-recruitment. Another conceptual advantage to APRV over controlled modes is the preservation of spontaneous breathing, which may pro-mote a redistribution of aeration to the dependent lung regions, less need for neuromuscular blockade and sedation, improved venous return and a better ventilation/perfusion (V/Q) matching. For this reason, APRV has been considered a tempting mode of ventilation during acute respiratory failure within the concept of open lung ventilation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIPAP group | Active comparator | Procedure: BIPAPBiphasic Intermittent Positive Airway Pressure group |
| APRV group | Active comparator | Procedure: APRVAirway Pressure Release Ventilation group: |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Critically ill trauma patients need mechanical ventilation
Key exclusion criteria (11 listed)
- Pregnant patient.
- Air leak from the chest tube.
- Patient with body temperature > 39 Celsius.
- Acute hepatitis or severe liver disease (Child-Pugh class C).
- Left ventricular ejection fraction less than 30%.
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 |
|---|---|---|
| BIPAPBiphasic Intermittent Positive Airway Pressure | Procedure or surgery | BIPAP group |
| APRVAirway Pressure Release Ventilation | Procedure or surgery | APRV group |
Primary outcome
energy expenditure
Time frame: 48 hours after enrollment
energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator
3 secondary outcomes
arterial oxygen tension
Time frame: 48 hours after enrollment
arterial carbon dioxide tension
Time frame: 48 hours after enrollment
arterial pH
Time frame: 48 hours after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingObservational study
DIAPHRAGM STRENGTH AND LUNG VOLUMES
Mechanical Ventilation
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing BIPAP and APRV in people with Mechanical Ventilation, run by Assiut University.
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 11 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
energy expenditure (time frame: 48 hours after enrollment). 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 20 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.