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Nurse's RoleNCT05797844

Improving the Endotracheal Tube Cuff Pressure Control Knowledge

A study testing Active implementational educational strategy and Passive implementational educational strategy in people with Nurse's Role, run by Kastamonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to evaluate how an educational intervention based on the existing evidence-based guidelines, using both active and passive educational implementetion strategies, could improve the knowledge of nurses regarding managing ETT cuff pressure control. Read more about this study

Who is it for?
Ages 18 to 47 yearsHealthy volunteers can take part
Conditions the study is for
Nurse's Role
What is being tested?
Active implementational educational strategy and Passive implementational educational strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Jun 2022to 29 Dec 2022
Phase
Interventional
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 47 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Working as a nurse in intensive care units
  • Nurses who participated in the theoretical training and visited for follow-up
  • Volunteer to participate in the study

Who cannot join

  • Not willing to participate in the study
  • Forms with missing answers were not included in the evaluation

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kastamonu University

    Kastamonu, 37100

Other trials in Turkey (Türkiye)

About this study

Official title: Improving the Endotracheal Tube Cuff Pressure Control Management Knowledge of Intensive Care Nurses: A Quasi-Experimental Study Pre-Post Test

This study aimed to evaluate how an educational intervention based on the existing evidence-based guidelines, using both active and passive educational implementetion strategies, could improve the knowledge of nurses regarding managing ETT cuff pressure control.

Hypothesis H1: There is a difference between the training given with the active and passive implementation strategies method in improving the endotracheal cuff pressure control knowledge of intensive care nurses.

Read the detailed description

This study was carried out as a quasi-experimental two-group pretest-posttest research design to evaluate the effect of endotracheal tube cuff pressure control training given with the active and passive implementation strategies methods on the knowledge level of nurses. The research was carried out in the intensive care units of a Training and Research Hospital, between June and December 2022, in 6 intensive care units (General ICU 1-General ICU 2- General ICU 3, CVC ICU, 2nd Level ICU, Coronary ICU).

In the intensive care unit of the hospital where the study was conducted, the endotracheal tube cuff pressure is controlled by the pilot balloon finger palpation method in four hours. In addition, pressure measurement was not made with the cuff manometer. However, in endotracheal tube cuff control, cuff pressure should be monitored to prevent aspiration and the cuff pressure should be kept between 20-30 cmH2O. Before the data of the study started to be collected, a cuff manometer was purchased by the hospital management to be used in the intensive care units.

The universe of the research consisted of 120 nurses working in the intensive care units where the study was conducted. The necessary sample of the study was determined by using G*Power computer software program version 3.0.1 as recommended to be used in calculating the desired sample by previous studies. The sample consisted of 90 nurses scheduled for, with a power value to represent 95% of the study population at a 80% confidence interval, 0.05 error level, and 0.6 effect size according to power analysis. Research Randomizer software (http://www.randomizer.org.) was used to generate a randomized list by applying a simple randomization technique to each participant's allocation. The 90 participants were divided into two even groups (Intervention Group =45, Control Group =43 nurses).

Sociodemographic and occupational characteristics form and knowledge level evaluation form regarding endotracheal tube cuff pressure control were used to collect the data of the study.

Since the nurses working in the intensive care unit work in day and night shifts, the sociodemographic and occupational characteristics form to be applied before the training and the knowledge level evaluation form on endotracheal tube cuff pressure control (pretest) were collected by the researchers after the nurses' shift delivery hours. After applying the pre-test questionnaires (experimental /Control group), on the days determined together with the intensive care unit nurses in charge and the nursing services directorate, all nurses were given theoretical training on endotracheal tube cuff pressure management through a 4-hour presentation prepared with evidence-based guide and literature. Thus, all nurses gained equal knowledge. A PowerPoint presentation including endotracheal tube cuff pressure normal values, complications related to endotracheal tube cuff pressure, management of endotracheal tube cuff pressure, endotracheal tube cuff pressure control methods, methods affecting endotracheal tube cuff pressure, how to measure endotracheal tube cuff pressure was made.

Nurses included in experimental group were trained through a 4-hour presentation (passive implementation strategy) prepared in the presence of evidence-based guidelines and literature, in addition, they were given a brochure about cuff pressure measurement and a brochure about cuff pressure was hung in the intensive care units where there are handwashing sinks. In addition, 4 follow-up visits (active implementation strategy) were carried out for ETT cuff pressure management using the one-on-one demonstration technique every 21 days. These follow-ups included adherence to evidence-based guidelines, nurses' application of endotracheal cuff pressure measurement and solving the problems encountered during its implementation. Uncertainties associated with evidence-based guidance on endotracheal tube cuff pressure control were clarified during these sessions. Nurses included in control group were trained through a 4-hour presentation (passive implamentation strategy) prepared in the presence of evidence-based guidelines and literature, in addition, they were given a brochure about cuff pressure measurement and a brochure about cuff pressure was hung in the intensive care units where there are handwashing sinks. No follow-up visits were made to this group. 3 months after the training, the Knowledge Level Evaluation Form (post-test) on Endotracheal Tube Cuff Pressure Control was re-applied to all nurses working in intensive care units and participating in the study.

The results of the study were analyzed in the IBM SPSS Statistics 23.0 (Statistical Package for Social Sciences IBM Corp., Armonk, NYC, USA) package program. Number, percentages, means, standard deviations, were used for descriptive statistics of demographic and occupational characteristics of the nurses. Correct answers to the questions on the knowledge level form were given one point each while incorrect ones were given zero points. The knowledge level scores were calculated by averaging the number of correct answers. The Shapiro-Wilk test was used for normality. The t-test was used to evaluate the education level between the intervention groups before and after the training. The Paired Sample t Test was used to compare the pre-training and post-training average scores for each groups. In all results, p<0.05 was considered statistically significant.

Conditions
Nurse's Role
Being tested
Active implementational educational strategy, Passive implementational educational strategy
Keywords
cuff pressure management, endotracheal tube cuff, educational intervention, intensive care nurses, nurses' knowledge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active implementational educational strategyOther

    Also called Experimental group

    4 follow-up visits (active implemantation strategy) were carried out for ETT cuff pressure management using the one-on-one demonstration technique every 21 days. These follow-ups included adherence to evidence-based guidelines, nurses' application of endotracheal cuff pressure measurement and solving the problems encountered during its implementation. Uncertainties associated with evidence-based guidance on endotracheal tube cuff pressure control were clarified during these sessions.

  • Passive implementational educational strategyOther

    Also called Control group

    Theoretical training on endotracheal tube cuff pressure management through a 4-hour presentation prepared with evidence-based guide and literature. A PowerPoint presentation including endotracheal tube cuff pressure normal values, complications related to endotracheal tube cuff pressure, management of endotracheal tube cuff pressure, endotracheal tube cuff pressure control methods, methods affecting endotracheal tube cuff pressure, how to measure endotracheal tube cuff pressure was made.

Study groups in NCT05797844
Study groupRoleWhat they receive
Experimental GroupExperimentalNurses included in experimental group were trained through a 4-hour presentation (passive implementation strategy) prepared in the presence of evidence-based guidelines and literature, in addition, they were given a brochure about cuff pressure measurement and a brochure about cuff pressure was hung in the intensive care units where there are handwashing sinks. In addition, 4 follow-up visits (active strategy) were carried out for ETT cuff pressure management using the one-on-one demonstration technique every 21 days.
Receives: Other: Active implementational educational strategy; Other: Passive implementational educational strategy
Control GroupActive comparatorNurses included in control group were trained through a 4-hour presentation (passive implementation strategy) prepared in the presence of evidence-based guidelines and literature, in addition, they were given a brochure about cuff pressure measurement and a brochure about cuff pressure was hung in the intensive care units where there are handwashing sinks.No follow-up visits were made to this group
Receives: Other: Passive implementational educational strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Knowledge Level Evaluation Form- Pre- test

    Knowledge level evaluation form on endotracheal tube cuff pressure control consists of 20 questions about the safe limits of endotracheal tube cuff pressure, complications of endotracheal tube cuff pressure that is not within safe limits, the factors affecting endotracheal cuff pressure, and the level of knowledge about endotracheal tube cuff pressure control methods and was prepared by researchers in line with the literature. While creating the survey, expert opinion was obtained. The 20-item knowledge level form was developed to assess the knowledge of nurses on ETT cuff pressure control by researchers. Only one item (part 1) had four answers options the range of ETT cuff pressure, "10-20cmH2O", "20-30 cmH2O", "30-40 cmH2O" and "above 40cmH2 O". Another items had two answers options, "correct" and "incorrect". While scoring, correct answers scored one point each, when incorrect answers options scored zero

    Measured: before theoretical training

  2. The Knowledge Level Evaluation Form-Post-test

    Knowledge level evaluation form on endotracheal tube cuff pressure control consists of 20 questions about the safe limits of endotracheal tube cuff pressure, complications of endotracheal tube cuff pressure that is not within safe limits, the factors affecting endotracheal cuff pressure, and the level of knowledge about endotracheal tube cuff pressure control methods and was prepared by researchers in line with the literature. While creating the survey, expert opinion was obtained. The 20-item knowledge level form was developed to assess the knowledge of nurses on ETT cuff pressure control by researchers. Only one item (part 1) had four answers options the range of ETT cuff pressure, "10-20cmH2O", "20-30 cmH2O", "30-40 cmH2O" and "above 40cmH2 O". Another items had two answers options, "correct" and "incorrect". While scoring, correct answers scored one point each, when incorrect answers options scored zero

    Measured: 3 months after theoretical training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start7 Jun 2022
  3. Primary completion29 Dec 2022
  4. Study completion29 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797844
Sponsor's protocol ID
2020-KAEK-143-59
Status last verified
Mar 2023
First submitted
3 Mar 2023
Last updated
4 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mpasa F, van Rooyen DRM, Venter D, Jordan P, Ten Ham-Baloyi W. Improving nurses' knowledge of managing endotracheal tube cuff pressure in intensive care units: A quasi-experimental study. Health SA. 2020 Dec 18;25:1479. doi: 10.4102/hsag.v25i0.1479. eCollection 2020.

    PubMed 33391829
  • Soyer Ö, Özyürek P, Yavuz van Giersbergen M. The Effect of Endotracheal Tube Cuff Pressure Control Training on Nurses' Knowledge Level. Turk J Intensive Care 2020;18:146-54.

  • Murugiah UR, Ramoo V, Jamaluddin MFH, Yahya A, Baharudin AA, Abu H, Thinagaran RRR. Knowledge acquisition and retention among nurses after an educational intervention on endotracheal cuff pressure. Nurs Crit Care. 2021 Sep;26(5):363-371. doi: 10.1111/nicc.12600. Epub 2021 Feb 10.

    PubMed 33569880

Questions about this trial

What is this clinical trial studying?

A study testing Active implementational educational strategy and Passive implementational educational strategy in people with Nurse's Role, run by Kastamonu University at 1 site in Turkey (Türkiye).

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 2 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 Apr 2023. 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 Turkey (Türkiye). 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?

The Knowledge Level Evaluation Form- Pre- test (time frame: before theoretical training). 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 NCT05797844, which also lists 3 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 Apr 2023.

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