Mechanical Ventilation in Multiple Fracture Ribs

July 6, 2018 updated by: Sayed Kaoud Abd-Elshafy, Assiut University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

  • 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).
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1

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
Device: 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
Active Comparator: Group 2

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
Device: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation
Time Frame: within one month
The total duration of ventilatory support in both groups from randomization to successful weaning (hours)
within one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resting Energy Expenditure
Time Frame: within the first 48 hours
Energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator [CARESCAPE R860]
within the first 48 hours
Physiological dead space
Time Frame: within the first 48 hours
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
within the first 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB0000879659

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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