NCT00997295

Brief Summary

The aim of the present study was to measure the inspired gas temperature and humidity of the anesthetic circuit in the Dräger Primus machine and esophageal temperature with or without and heat and moisture exchanger (HME) and low-flow gas during anesthesia in patients submitted to gynecological surgeries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
Last Updated

October 19, 2009

Status Verified

October 1, 2009

Enrollment Period

1.4 years

First QC Date

October 16, 2009

Last Update Submit

October 16, 2009

Conditions

Gynecological SurgeryGeneral Anesthesia

Keywords

low flow gasHeat and moisture exchangerHumidityTemperatureCore temperatureWomen

Study Arms (4)

Heat moisture exchanger (HME)

This group was submitted to general anesthesia with low flow gas and heat moisture exchanger

Low flow gas (LFG)

This group was submitted to general anesthesia with only low flow gas

Humidity of the respiration

Heat and moisture group: The first group (G1)will be submitted to low flow gas anesthesia and heat and moisture exchanger (HME) Control group: The second group(G2)Will be submitted to low flow gas anesthesia

HME and LFG

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Thirty adult patients scheduled to gynecologic surgeries were randomly assigned in two groups to received fresh gas flow of 1 l.min-1 with or without in circle anesthesia system. Relative humidity, absolute humidity, temperature of gases and esophageal temperature were measured at 15 min (T0)after respiratory circuit installation and then every 30 min up to 120 min afterwards.

You may qualify if:

  • Women
  • to 69 years old
  • Gynecological

You may not qualify if:

  • Obesity
  • Fever
  • Endocrine disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine of Botucatu

Botucatu, São Paulo, 18618000, Brazil

Location

Related Publications (1)

  • de Castro J Jr, Bolfi F, de Carvalho LR, Braz JR. The temperature and humidity in a low-flow anesthesia workstation with and without a heat and moisture exchanger. Anesth Analg. 2011 Sep;113(3):534-8. doi: 10.1213/ANE.0b013e31822402df. Epub 2011 Jun 16.

    PMID: 21680862DERIVED

Study Officials

  • Jair Castro Jr, MD

    Botucatu Medical Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 19, 2009

Study Start

January 1, 2007

Primary Completion

June 1, 2008

Study Completion

September 1, 2009

Last Updated

October 19, 2009

Record last verified: 2009-10

Locations

BR(1)