NCT06536972

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 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

June 1, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 4, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

June 14, 2024

Last Update Submit

November 1, 2024

Conditions

Keywords

Heat and moisture exchangersHeated humidifiersQuestionnaire

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    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"

    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"

    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"

    From June 1 to August 30

Interventions

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is health professionals who work in Intensive Care Units in Latin America

You may qualify if:

  • 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)

You may not qualify if:

  • ≥10% missing survey data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Britanico de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280AED, Argentina

Location

Related Publications (26)

  • 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.

    PMID: 10764013BACKGROUND
  • Lindemann 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.

    PMID: 12071984BACKGROUND
  • Mercke 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.

    PMID: 4432749BACKGROUND
  • Walker 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.

    PMID: 1068640BACKGROUND
  • Rathgeber 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.

    PMID: 12107679BACKGROUND
  • BURTON 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.

    PMID: 13875072BACKGROUND
  • Dery 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.

    PMID: 4704875BACKGROUND
  • Eckerbom 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.

    PMID: 2389657BACKGROUND
  • Cohen 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.

    PMID: 3422625BACKGROUND
  • Branson 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
  • 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.

    PMID: 9539071BACKGROUND
  • Wilkes AR. Heat and moisture exchangers. Structure and function. Respir Care Clin N Am. 1998 Jun;4(2):261-79.

    PMID: 9648186BACKGROUND
  • Martin 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.

    PMID: 7956294BACKGROUND
  • Martin 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.

    PMID: 7750340BACKGROUND
  • Plotnikow 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.

    PMID: 29742220BACKGROUND
  • Branson RD. Humidification for patients with artificial airways. Respir Care. 1999;44(6):630-41

    BACKGROUND
  • Oh TE, Lin ES, Bhatt S. Resistance of humidifiers, and inspiratory work imposed by a ventilator-humidifier circuit. Br J Anaesth. 1991 Feb;66(2):258-63. doi: 10.1093/bja/66.2.258.

    PMID: 1817633BACKGROUND
  • Roux NG, Plotnikow GA, Villalba DS, Gogniat E, Feld V, Ribero Vairo N, Sartore M, Bosso M, Scapellato JL, Intile D, Planells F, Noval D, Bunirigo P, Jofre R, Diaz Nielsen E. Evaluation of an active humidification system for inspired gas. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):69-75. doi: 10.3342/ceo.2015.8.1.69. Epub 2015 Feb 3.

    PMID: 25729499BACKGROUND
  • Ari A, Alwadeai KS, Fink JB. Effects of Heat and Moisture Exchangers and Exhaled Humidity on Aerosol Deposition in a Simulated Ventilator-Dependent Adult Lung Model. Respir Care. 2017 May;62(5):538-543. doi: 10.4187/respcare.05015. Epub 2017 Mar 7.

    PMID: 28270542BACKGROUND
  • Thomachot L, Viviand X, Boyadjiev I, Vialet R, Martin C. The combination of a heat and moisture exchanger and a Booster: a clinical and bacteriological evaluation over 96 h. Intensive Care Med. 2002 Feb;28(2):147-53. doi: 10.1007/s00134-001-1193-2. Epub 2002 Jan 12.

    PMID: 11907657BACKGROUND
  • Branson RD, Campbell RS, Johannigman JA, Ottaway M, Davis K Jr, Luchette FA, et al. Comparison of conventional heated humidification with a new active hygroscopic heat and moisture exchanger in mechanically ventilated patients. Respir Care. 1999;44(8):912-7.

    BACKGROUND
  • Siempos II, Vardakas KZ, Kopterides P, Falagas ME. Impact of passive humidification on clinical outcomes of mechanically ventilated patients: a meta-analysis of randomized controlled trials. Crit Care Med. 2007 Dec;35(12):2843-51. doi: 10.1097/01.ccm.0000295302.67973.9a.

    PMID: 18074484BACKGROUND
  • Kelly M, Gillies D, Todd DA, Lockwood C. Heated humidification versus heat and moisture exchangers for ventilated adults and children. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD004711. doi: 10.1002/14651858.CD004711.pub2.

    PMID: 20393939BACKGROUND
  • Klompas M, Branson R, Eichenwald EC, Greene LR, Howell MD, Lee G, Magill SS, Maragakis LL, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S133-54. doi: 10.1017/s0899823x00193894. No abstract available.

    PMID: 25376073BACKGROUND
  • Prin S, Chergui K, Augarde R, Page B, Jardin F, Vieillard-Baron A. Ability and safety of a heated humidifier to control hypercapnic acidosis in severe ARDS. Intensive Care Med. 2002 Dec;28(12):1756-60. doi: 10.1007/s00134-002-1520-2. Epub 2002 Oct 8.

    PMID: 12447519BACKGROUND
  • American Association for Respiratory Care; Restrepo RD, Walsh BK. Humidification during invasive and noninvasive mechanical ventilation: 2012. Respir Care. 2012 May;57(5):782-8. doi: 10.4187/respcare.01766.

    PMID: 22546299BACKGROUND

MeSH Terms

Conditions

Behavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 14, 2024

First Posted

August 5, 2024

Study Start

June 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

November 4, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations