Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content

NCT01943227 | Completed Results

• 1 other identifier: 483184
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ventilation Perfusion Mismatch

Keywords

humidity; enthalpy; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Other: controlled positive pressure ventilation 6ml/kg tidal volume

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.

Other: controlled positive pressure ventilation 9ml/kg tidal volume

Interventions

controlled positive pressure ventilation 9ml/kg tidal volume OTHER

controlled positive pressure ventilation 9ml/kg tidal volume

9ml/kg

controlled positive pressure ventilation 6ml/kg tidal volume OTHER

controlled positive pressure ventilation 6ml/kg tidal volume

6ml/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients without cardiac or respiratory illness

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health System

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Tidal Volume

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Neal Fleming, MD, PhD
• Organization: UC Davis Medical Center

nwfleming@ucdavis.edu

916-734-5046

Study Officials

• Neal Fleming, MD, PhD

  Professor, Anesthesiology & Pain Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 16, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 28, 2019
• Results First Posted: October 28, 2019

Record last verified: 2019-10

Locations

US (1)