Survey, Family LifeNCT06536972
Dual-focus Survey with an Emphasis on Heated Humidification Systems
An observational study of Survey, Family Life and Knowledge, Attitudes, Practice, run by Argentinian Intensive Care Society at 1 site in Argentina.
Trial summary
Under normal circumstances the upper airway and respiratory tract play a crucial role in humidifying and warming inhaled air, a process known as inspired gas conditioning. This process is essential for effective gas conditioning and mitigating the potential risk of damaging the structure and function of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survey, Family Life, Knowledge, Attitudes, Practice
- What is being tested?
- knowledge
- How many people
- 500 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jun 2024to 31 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is health professionals who work in Intensive Care Units in Latin America
Who may be able to join
- Doctor, nurse, respiratory therapist or related titles
- More than 2 years of work experience in an adult ICU (work in the ICU will be considered as work carried out at least 12 hours per week in the critical care unit)
Who cannot join
- ≥10% missing survey data
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Britanico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280AED
About this study
Under normal circumstances the upper airway and respiratory tract play a crucial role in humidifying and warming inhaled air, a process known as inspired gas conditioning. This process is essential for effective gas conditioning and mitigating the potential risk of damaging the structure and function of the respiratory epithelium. Airway instrumentation, such as the use of an orotracheal tube or tracheostomy cannula, interferes with the physiological conditioning of inspired gas. Furthermore, the administration of cold, dry medical gases, together with the high flows experienced by patients under invasive mechanical ventilation (IVM) or non-invasive mechanical ventilation (NIMV), exacerbate this unfavorable condition. Therefore, the incorporation of an external device to condition the delivered gas becomes imperative, even in short-term interventions.
There are different devices to condition the inhaled gas, basically passive humidification systems (HMEF) and active (or heated) systems. Considering the humidification capacity and advantages and disadvantages, both passive and active systems are suitable for conditioning the inhaled gas.
Read more
The hyphotesis of this study is that health teams in Latin America have limited knowledge regarding humidification systems, both from the technical aspects of implementation and from the clinic.
OBJECTIVES
Primary aim:
Develop an instrument to evaluate knowledge about humidification systems among different health professionals in intensive care units (ICU).
Describe the knowledge about humidification systems among different health professionals in intensive care units (ICU).
Secondary aim:
Compare knowledge about humidification systems between different countries. Compare knowledge about humidification systems between different specialties. Compare knowledge about humidification systems in different age groups.
- Being tested
- knowledge
- Keywords
- Heat and moisture exchangers, Heated humidifiers, Questionnaire
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knowledgeOther
Develop an instrument to evaluate knowledge about humidification systems among different health professionals in intensive care units (ICU).
Describe the knowledge about humidification systems among different health professionals in intensive care units (ICU).
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop questionnaire named "Double-Focus Survey with Emphasis on Active Heated Humidification Systems"
Develop an questionnaire to evaluate knowledge about humidification systems among different health professionals in intensive care units (ICU).
Measured: From April 1 to April 30
Describe the knowledge using the questionnaire previously developed
Measure the level of knowledge among different health professionals in ICU settings using the developed questionnaire named "Double-Focus Survey with Emphasis on Active Heated Humidification Systems". This assessment will include evaluating the understanding of the principles, usage, and maintenance of humidification systems.
Measured: From June 1 to August 30
Secondary outcomes (3)
Compare knowledge about humidification systems between different countries using the questionnaire "Double-Focus Survey with Emphasis on Active Heated Humidification Systems"
Measured: From June 1 to August 30
Describe and compare the knowledge about humidification systems between different specialties using the questionnaire "Double-Focus Survey with Emphasis on Active Heated Humidification Systems"
Stratification by specialities for describe and compare the knowledge about humidification systems.
Measured: From June 1 to August 30
Describe and compare knowledge about humidification systems in different age groups using the queationnaire "Double-Focus Survey with Emphasis on Active Heated Humidification Systems"
Stratification by age for describe and compare the knowledge about humidification systems.
Measured: From June 1 to August 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jun 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Survey, Family LifeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argentinian Intensive Care Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Plotnikow, Argentinian Intensive Care Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536972
- Sponsor's protocol ID
- PRIISABA-CRIHB #12359
- Status last verified
- Aug 2024
- First submitted
- 14 Jun 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Keck T, Leiacker R, Riechelmann H, Rettinger G. Temperature profile in the nasal cavity. Laryngoscope. 2000 Apr;110(4):651-4. doi: 10.1097/00005537-200004000-00021.
PubMed 10764013Lindemann J, Leiacker R, Rettinger G, Keck T. Nasal mucosal temperature during respiration. Clin Otolaryngol Allied Sci. 2002 Jun;27(3):135-9. doi: 10.1046/j.1365-2273.2002.00544.x.
PubMed 12071984Mercke U. The influence of temperature on mucociliary activity. Temperature range 40 degrees C to 50 degrees C. Acta Otolaryngol. 1974 Sep-Oct;78(3-4):253-8. doi: 10.3109/00016487409126352. No abstract available.
PubMed 4432749Walker AK, Bethune DW. A comparative study of condenser humidifiers. Anaesthesia. 1976 Oct;31(8):1086-93. doi: 10.1111/j.1365-2044.1976.tb11950.x.
PubMed 1068640Rathgeber J, Kazmaier S, Penack O, Zuchner K. Evaluation of heated humidifiers for use on intubated patients: a comparative study of humidifying efficiency, flow resistance, and alarm functions using a lung model. Intensive Care Med. 2002 Jun;28(6):731-9. doi: 10.1007/s00134-002-1275-9. Epub 2002 Apr 26.
PubMed 12107679BURTON JD. Effects of dry anaesthetic gases on the respiratory mucous membrane. Lancet. 1962 Feb 3;1(7223):235-8. doi: 10.1016/s0140-6736(62)91187-x. No abstract available.
PubMed 13875072Dery R. The evolution of heat and moisture in the respiratory tract during anaesthesia with a non-rebreathing system. Can Anaesth Soc J. 1973 May;20(3):296-309. doi: 10.1007/BF03027168. No abstract available.
PubMed 4704875Eckerbom B, Lindholm CE. Performance evaluation of six heat and moisture exchangers according to the Draft International Standard (ISO/DIS 9360). Acta Anaesthesiol Scand. 1990 Jul;34(5):404-9. doi: 10.1111/j.1399-6576.1990.tb03112.x.
PubMed 2389657Cohen IL, Weinberg PF, Fein IA, Rowinski GS. Endotracheal tube occlusion associated with the use of heat and moisture exchangers in the intensive care unit. Crit Care Med. 1988 Mar;16(3):277-9. doi: 10.1097/00003246-198803000-00013.
PubMed 3422625Branson R, Davis K Jr. Evaluation of 21 passive humidifiers according to the ISO 9360 standard: moisture output, dead space, and flow resistance. Respir Care. 1996;41:736-43
Unal N, Kanhai JK, Buijk SL, Pompe JC, Holland WP, Gultuna I, Ince C, Saygin B, Bruining HA. A novel method of evaluation of three heat-moisture exchangers in six different ventilator settings. Intensive Care Med. 1998 Feb;24(2):138-46. doi: 10.1007/s001340050535.
PubMed 9539071Wilkes AR. Heat and moisture exchangers. Structure and function. Respir Care Clin N Am. 1998 Jun;4(2):261-79.
PubMed 9648186Martin C, Papazian L, Perrin G, Saux P, Gouin F. Preservation of humidity and heat of respiratory gases in patients with a minute ventilation greater than 10 L/min. Crit Care Med. 1994 Nov;22(11):1871-6.
PubMed 7956294Martin C, Thomachot L, Quinio B, Viviand X, Albanese J. Comparing two heat and moisture exchangers with one vaporizing humidifier in patients with minute ventilation greater than 10 L/min. Chest. 1995 May;107(5):1411-5. doi: 10.1378/chest.107.5.1411.
PubMed 7750340Plotnikow GA, Accoce M, Navarro E, Tiribelli N. Humidification and heating of inhaled gas in patients with artificial airway. A narrative review. Rev Bras Ter Intensiva. 2018 Mar;30(1):86-97. doi: 10.5935/0103-507x.20180015.
PubMed 29742220
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-focus Survey with an Emphasis on Heated Humidification Systems
- ClinicalTrials.gov ID
- NCT06536972
- Acronym / sponsor ID
- PRIISABA-CRIHB #12359
- Keywords
- Heat and moisture exchangers, Heated humidifiers, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Argentinian Intensive Care SocietyUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 5 Aug 2024 (actual)
- 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.
Under normal circumstances the upper airway and respiratory tract play a crucial role in humidifying and warming inhaled air, a process known as inspired gas conditioning. This process is essential for effective gas conditioning and mitigating the potential risk of damaging the structure and function of the respiratory epithelium. Airway instrumentation, such as the use of an orotracheal tube or tracheostomy cannula, interferes with the physiological conditioning of inspired gas. Furthermore, the administration of cold, dry medical gases, together with the high flows experienced by patients under invasive mechanical ventilation (IVM) or non-invasive mechanical ventilation (NIMV), exacerbate this unfavorable condition. Therefore, the incorporation of an external device to condition the delivered gas becomes imperative, even in short-term interventions.
There are different devices to condition the inhaled gas, basically passive humidification systems (HMEF) and active (or heated) systems. Considering the humidification capacity and advantages and disadvantages, both passive and active systems are suitable for conditioning the inhaled gas.
The hyphotesis of this study is that health teams in Latin America have limited knowledge regarding humidification systems, both from the technical aspects of implementation and from the clinic.
OBJECTIVES
Primary aim:
Develop an instrument to evaluate knowledge about humidification systems among different health professionals in intensive care units (ICU).
Describe the knowledge about humidification systems among different health professionals in intensive care units (ICU).
Secondary aim:
Compare knowledge about humidification systems between different countries. Compare knowledge about humidification systems between different specialties. Compare knowledge about humidification systems in different age groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is health professionals who work in Intensive Care Units in Latin America
Key inclusion criteria (2 listed)
- Doctor, nurse, respiratory therapist or related titles
- More than 2 years of work experience in an adult ICU (work in the ICU will be considered as work carried out at least 12 hours per week in the critical care unit)
Key exclusion criteria (1 listed)
- ≥10% missing survey data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| knowledgeDevelop an instrument to evaluate knowledge about humidification systems among different health professionals in intensive care units (ICU). Describe the knowledge about humidification systems among different health professionals in intensive care units (ICU). | Other | – |
Primary outcome
Develop questionnaire named "Double-Focus Survey with Emphasis on Active Heated Humidification Systems"
Time frame: From April 1 to April 30
Develop an questionnaire to evaluate knowledge about humidification systems among different health professionals in intensive care units (ICU).
Describe the knowledge using the questionnaire previously developed
Time frame: From June 1 to August 30
Measure the level of knowledge among different health professionals in ICU settings using the developed questionnaire named "Double-Focus Survey with Emphasis on Active Heated Humidification Systems". This assessment will include evaluating the understanding of the principles, usage, and maintenance of humidification systems.
3 secondary outcomes
Compare knowledge about humidification systems between different countries using the questionnaire "Double-Focus Survey with Emphasis on Active Heated Humidification Systems"
Time frame: From June 1 to August 30
Describe and compare the knowledge about humidification systems between different specialties using the questionnaire "Double-Focus Survey with Emphasis on Active Heated Humidification Systems"
Time frame: From June 1 to August 30
Describe and compare knowledge about humidification systems in different age groups using the queationnaire "Double-Focus Survey with Emphasis on Active Heated Humidification Systems"
Time frame: From June 1 to August 30
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 4 Nov 2024.
- Background: PubMed 10764013Keck T, Leiacker R, Riechelmann H, Rettinger G. Temperature profile in the nasal cavity. Laryngoscope. 2000 Apr;110(4):651-4. doi: 10.1097/00005537-200004000-00021.
- Background: PubMed 12071984Lindemann J, Leiacker R, Rettinger G, Keck T. Nasal mucosal temperature during respiration. Clin Otolaryngol Allied Sci. 2002 Jun;27(3):135-9. doi: 10.1046/j.1365-2273.2002.00544.x.
- Background: PubMed 4432749Mercke U. The influence of temperature on mucociliary activity. Temperature range 40 degrees C to 50 degrees C. Acta Otolaryngol. 1974 Sep-Oct;78(3-4):253-8. doi: 10.3109/00016487409126352. No abstract available.
- Background: PubMed 1068640Walker AK, Bethune DW. A comparative study of condenser humidifiers. Anaesthesia. 1976 Oct;31(8):1086-93. doi: 10.1111/j.1365-2044.1976.tb11950.x.
- Background: PubMed 12107679Rathgeber J, Kazmaier S, Penack O, Zuchner K. Evaluation of heated humidifiers for use on intubated patients: a comparative study of humidifying efficiency, flow resistance, and alarm functions using a lung model. Intensive Care Med. 2002 Jun;28(6):731-9. doi: 10.1007/s00134-002-1275-9. Epub 2002 Apr 26.
- Background: PubMed 13875072BURTON JD. Effects of dry anaesthetic gases on the respiratory mucous membrane. Lancet. 1962 Feb 3;1(7223):235-8. doi: 10.1016/s0140-6736(62)91187-x. No abstract available.
- Background: PubMed 4704875Dery R. The evolution of heat and moisture in the respiratory tract during anaesthesia with a non-rebreathing system. Can Anaesth Soc J. 1973 May;20(3):296-309. doi: 10.1007/BF03027168. No abstract available.
- Background: PubMed 2389657Eckerbom B, Lindholm CE. Performance evaluation of six heat and moisture exchangers according to the Draft International Standard (ISO/DIS 9360). Acta Anaesthesiol Scand. 1990 Jul;34(5):404-9. doi: 10.1111/j.1399-6576.1990.tb03112.x.
- Background: PubMed 3422625Cohen IL, Weinberg PF, Fein IA, Rowinski GS. Endotracheal tube occlusion associated with the use of heat and moisture exchangers in the intensive care unit. Crit Care Med. 1988 Mar;16(3):277-9. doi: 10.1097/00003246-198803000-00013.
- BackgroundBranson R, Davis K Jr. Evaluation of 21 passive humidifiers according to the ISO 9360 standard: moisture output, dead space, and flow resistance. Respir Care. 1996;41:736-43
- Background: PubMed 9539071Unal N, Kanhai JK, Buijk SL, Pompe JC, Holland WP, Gultuna I, Ince C, Saygin B, Bruining HA. A novel method of evaluation of three heat-moisture exchangers in six different ventilator settings. Intensive Care Med. 1998 Feb;24(2):138-46. doi: 10.1007/s001340050535.
- Background: PubMed 9648186Wilkes AR. Heat and moisture exchangers. Structure and function. Respir Care Clin N Am. 1998 Jun;4(2):261-79.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Survey, Family Life and Knowledge, Attitudes, Practice, run by Argentinian Intensive Care Society at 1 site in Argentina.
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 2 inclusion and 1 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 4 Nov 2024. 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 Argentina. 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.
What does the primary outcome measure?
Develop questionnaire named "Double-Focus Survey with Emphasis on Active Heated Humidification Systems" (time frame: From April 1 to April 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06536972, which also lists 26 linked publications.
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 4 Nov 2024.