An observational study in Ventilation Perfusion Mismatch, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-28.
Sponsored by University of California, Davis · Observational
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)
University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
adult patients without cardiac or respiratory illness
Exclusion Criteria:
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.
Other: controlled positive pressure ventilation 6ml/kg tidal volume
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.
Other: controlled positive pressure ventilation 9ml/kg tidal volume
controlled positive pressure ventilation 9ml/kg tidal volume
controlled positive pressure ventilation 6ml/kg tidal volume
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.
Time frame: 12 months
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.
| Milestone | Large Tidal Volume | Smal Tidal Volume |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| Joules/Minute | Large Tidal Volume | Smal Tidal Volume |
|---|---|---|
| Airway Enthalpy | 32 ± 9.1 | 23 ± 8.9 |
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Large Tidal Volume | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Small Tidal Volume | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
The study will enroll adult patients without cardiac or respiratory illness.
| Age, Categorical(Participants) | Large Tidal Volume | Small Tidal Volume | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | Large Tidal Volume | Small Tidal Volume | Total |
|---|---|---|---|
| Mean | 44 ± 10.8 | 42 ± 13.8 | 43 ± 12.5 |
| Sex: Female, Male(Participants) | Large Tidal Volume | Small Tidal Volume | Total |
|---|---|---|---|
| Female | 6 | 3 | 9 |
| Male | 4 | 7 | 11 |
| Region of Enrollment(participants) | Large Tidal Volume | Small Tidal Volume | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of California, Davis