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This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy).
This is a single site, prospective, non-blinded, non-randomized, noninterventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy). Each patient will serve as their own control. The study will enroll adult patients without cardiac or respiratory illness. It is designed to evaluate the effect of the ventilatory pattern (tidal volume, rate) on respiratory heat loss measured using the VQm™ monitor during standard intra-operative clinical care that requires positive pressure ventilation (PPV)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6ml/kg | Enthalpy measured in patients receiving controlled positive pressure ventilation 6ml/kg Tidal volume. The VQm monitor samples the gas at a rate of 3 L/min, returning the analyzed gas to the circuit. As the exhaled gas passes through the analytical chamber, the temperature and humidity are measured essentially continuously (40Hz). These data are combined with pressure measurements to determine the exhaled gas volume and then the heat content (enthalpy) is calculated. |
| |
| 9ml/kg | Enthalpy measured in patients receiving controlled positive pressure ventilation 9ml/kg Tidal volume. The VQm monitor samples the gas at a rate of 3 L/min, returning the analyzed gas to the circuit. As the exhaled gas passes through the analytical chamber, the temperature and humidity are measured essentially continuously (40Hz). These data are combined with pressure measurements to determine the exhaled gas volume and then the heat content (enthalpy) is calculated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| controlled positive pressure ventilation 9ml/kg tidal volume | Other | controlled positive pressure ventilation 9ml/kg tidal volume |
|
| Measure | Description | Time Frame |
|---|---|---|
| Airway Enthalpy | This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy) in Joules per minute. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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adult patients without cardiac or respiratory illness
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| Name | Affiliation | Role |
|---|---|---|
| Neal Fleming, MD, PhD | Professor, Anesthesiology & Pain Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Health System | Sacramento | California | 95817 | United States |
The screening of patients will require the investigators to access personal health information to identify prospective subjects without HIPAA authorization. The research could not be practicably carried out without this waiver of consent. The risk of harm from contacting the participants is greater than the risk of the study procedures.
Patient recruitment and informed consent will be obtained in the UCDMC perioperative suite. Recruitment will be by direct discussion between the prospective candidates and the study investigators prior to their scheduled surgical procedure. The investigators will provide the consent form in person and give subject time to discuss with family.
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| ID | Title | Description |
|---|---|---|
| FG000 | Large Tidal Volume | Change in airway heat content |
| FG001 | Smal Tidal Volume | Change in airway heat content |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study will enroll adult patients without cardiac or respiratory illness.
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| ID | Title | Description |
|---|---|---|
| BG000 | Large Tidal Volume | Airway heat content |
| BG001 | Small Tidal Volume | Airway heat content |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Airway Enthalpy | This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy) in Joules per minute. | Posted | Mean | Standard Deviation | Joules/Minute | 12 months |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Large Tidal Volume | Airway heat content | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neal Fleming, MD, PhD | UC Davis Medical Center | 916-734-5046 | nwfleming@ucdavis.edu |
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| ID | Term |
|---|---|
| D013990 | Tidal Volume |
| ID | Term |
|---|---|
| D007320 | Inspiratory Capacity |
| D014797 | Vital Capacity |
| D014109 | Total Lung Capacity |
| D008176 | Lung Volume Measurements |
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| controlled positive pressure ventilation 6ml/kg tidal volume | Other | controlled positive pressure ventilation 6ml/kg tidal volume |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | The study will enroll adult patients without cardiac or respiratory illness. | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Small Tidal Volume | Airway heat content | 0 | 10 | 0 | 10 | 0 | 10 |
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| D012129 |
| Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |