Trial Outcomes & Findings for Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content (NCT NCT01943227)

NCT ID: NCT01943227

Last Updated: 2019-10-28

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-10-28

Participant Flow

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.

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.

Participant milestones

Measure	Large Tidal Volume Change in airway heat content	Smal Tidal Volume Change in airway heat content
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content

Baseline characteristics by cohort

Measure	Large Tidal Volume n=10 Participants Airway heat content	Small Tidal Volume n=10 Participants Airway heat content	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44 Years STANDARD_DEVIATION 10.8 • n=5 Participants	42 Years STANDARD_DEVIATION 13.8 • n=7 Participants	43 Years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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.

Outcome measures

Measure	Large Tidal Volume n=10 Participants Change in airway heat content	Smal Tidal Volume n=10 Participants Change in airway heat content
Airway Enthalpy	32 Joules/Minute Standard Deviation 9.1	23 Joules/Minute Standard Deviation 8.9

Adverse Events

Large Tidal Volume

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Small Tidal Volume

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Neal Fleming, MD, PhD

UC Davis Medical Center

Phone: 916-734-5046

Email: nwfleming@ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place