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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

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 groups in NCT04205422
Study groupRoleWhat they receive
BIPAP groupActive comparatorBiphasic Intermittent Positive Airway Pressure group
Receives: Procedure: BIPAP
APRV groupActive comparatorAirway Pressure Release Ventilation group:
Receives: Procedure: APRV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. arterial oxygen tension

    measured from arterial sample

    Measured: 48 hours after enrollment

  2. arterial carbon dioxide tension

    measured from arterial sample

    Measured: 48 hours after enrollment

  3. 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.

  1. First posted19 Dec 2019
  2. Study start1 Jan 2020 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Resources

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)
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

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.

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