Gynecological SurgeryNCT00997295
Heat and Moisture Exchanger and Low-flow Gas
An observational study of Gynecological Surgery and General Anesthesia, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Gynecological Surgery, General Anesthesia
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Women
- 18 to 69 years old
- Gynecological
Who cannot join
- Obesity
- Fever
- Endocrine disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Heat and Moisture Exchanger on Temperature and Humidity in Low -Flow Anesthesia Workstation
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.
- Conditions
- Gynecological Surgery, General Anesthesia
- Keywords
- low flow gas, Heat and moisture exchanger, Humidity, Temperature, Core temperature, Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecological SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Jair Castro Jr, MD, Principal investigator, Botucatu Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997295
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-29
- Status last verified
- Oct 2009
- First submitted
- 16 Oct 2009
- Last updated
- 19 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21680862
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Heat and Moisture Exchanger on Temperature and Humidity in Low -Flow Anesthesia Workstation
- ClinicalTrials.gov ID
- NCT00997295
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-29
- Conditions
- Gynecological Surgery, General Anesthesia
- Keywords
- low flow gas, Heat and moisture exchanger, Humidity, Temperature, Core temperature, Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Women
- 18 to 69 years old
- Gynecological
Key exclusion criteria (3 listed)
- Obesity
- Fever
- Endocrine disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2009.
- Derived from this study: PubMed 21680862de 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.
Related trials for Gynecological Surgery
RecruitingObservational study
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GYN Disorders
Active, not recruiting
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
Gynecologic Surgery
Enrolling by invitation
Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS Based on the Mobile Application
Gynecologic Surgery, General Anesthesia
Recruiting
Surgical Ergonomics in OBGYN
Current OBGYN Attending, Resident, or Fellow at University Hospitals
Not yet recruitingPhase 4
Perioperative Esketamine Safety and Efficacy in Reducing Postoperative ENDometriosis PAIN (the ENDPAIN Trial): a Randomized Controlled Trial.
Endometriosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jair Castro Jr, MD principal investigator
Botucatu Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecological Surgery and General Anesthesia, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00997295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2009.