Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content

Ventilation Perfusion Mismatch Clinical Trial

Official title:

Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943227
• Other study ID #: 483184
• Status: Completed
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age greater than 18 years

• scheduled for an elective surgical procedure with an anticipated duration of more than 2 hours requiring general anesthesia and positive pressure ventilation using an endotracheal tube

• patient status ASA 1, 2 or 3

• no significant cardio-vascular or respiratory disease

• supine surgical position

Exclusion Criteria:

• Adults unable to give primary consent

• age less than 18 years

• pregnancy

• prisoners

• pre-existing cardiac or pulmonary disease

• infusion of inotropic drugs

• positive end expiratory pressure (PEEP) requirements >8 cm H2O

• increased intra-abdominal pressure (e.g. planned surgical pneumoperitoneum or ascitis)

• intra-operative patient position other than supine

Related Conditions & MeSH terms

• Ventilation Perfusion Mismatch

Intervention

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
controlled positive pressure ventilation 6ml/kg tidal volume

Locations

Country	Name	City	State
United States	UC Davis Health System	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months