Clinical question
Should any preventive dressing versus no preventive dressing be used for people at risk of device-related pressure injuries?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Conflicts on Interest:
People at risk of heel pressure injuries from endotracheal tubes (ETTs)
An ETT fixation device
Adhesive tape
Any clinical setting
ETT-related pressure injury (PI) occurrence
No Guideline Governance Group members of Core Review Group members had a conflict of interest
Evidence to Decision Framework
(Click on the individual judgements for more information)
Summary of Judgements
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Yes
Large
Varies
Very low
No important uncertainty or variability
Probably favors the intervention
Moderate costs
Low
No included studies
Probably increased
Probably yes
Probably yes
1. Problem:
Is the problem (pressure injuries) a priority?
JUDGEMENT
No
Probably No
Probably Yes
Yes
Varies
Don’t Know
RESEARCH EVIDENCE
The problem of preventing pressure injuries is a significant priority to healthcare in most clinical settings. In a stakeholder survey conducted by the Guideline Governance Group in 2021, the target audiences for the guideline, generally rated prevention of device-related pressure injuries (DRPI) as a high priority. Receiving clinical guidance on interventions to prevent DRPIs were rated as being the highest priority (median ranking 5/5, where 5 is the highest priority) by health professionals, researchers and industry representatives. Individuals with or at risk of PIs and their informal carers rated interventions to prevent DRPIs as being of high priority (median ranking 4/5).
In an earlier survey conducted by the previous Guideline Governance Group in 2018(Haesler, Pittman et al. 2022), 78.77% (256/325) of individuals with or at risk of PIs and 82.44% (554/672) of informal carers rated receiving information on caring for skin around medical devices as important or very important.
2. Desirable Effects:
How substantial are the desirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
| Outcome | ETT fixation device |
Adhesive tape |
Difference | Relative effect |
|---|---|---|---|---|
| Reduction in ETT-related PI occurrence | 44/5374 (0.8%) | 104/5374 (3.3%) | 21 fewer PIs per 1,000 (from 29 fewer to 3 more) |
RR 0.36 (0.12-1.10) |
Outcome 1: Reduction in DRPI (ETT-related) occurrence
The meta-analysis included five comparative studies(Zaratkiewicz, Teegardin et al. 2012, Hampson, Green et al. 2018, Landsperger, Byram et al. 2019, Coyer, Cook et al. 2020, Kuniavsky, Vilenchik et al. 2020) that compared using an endotracheal tube (ETT) fixation device to using adhesive tape for preventing ETT-related PIs. Two of these studies were randomized controlled trials (RCTs).(Landsperger, Byram et al. 2019, Coyer, Cook et al. 2020) All the studies explored the same commercial fixation device[*] that is designed with moisture resistant barrier pads and adjustable straps, and secures the ETT tube off the individual’s lip. In the included studies, the ETT fixation device was for 1 to 2 weeks. The studies either excluded individuals placed in the prone position or did not report positioning. The ETT-related PIs that are reported in studies occurred on the lips/mouth/mucous membranes.(Zaratkiewicz, Teegardin et al. 2012, Hampson, Green et al. 2018, Landsperger, Byram et al. 2019, Kuniavsky, Vilenchik et al. 2020) The meta-analysis showed that using an ETT fixation device was associated with a non-significant lower rate of ETT-related PIs (RR 0.36, 95% CI 0.12 to 1.10, p = 0.07), translating to a difference of 21 fewer per 1,000 experiencing an ETT-related PI when a fixation device is used. However, the evidence was of very low quality. It is very uncertain if the result represents a true effect; the true effect lies between 29 fewer people and 3 more people experiencing an ETT-related PI with a fixation device compared with adhesive tape.
[*] Devices are described in the data extraction tables.
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
Most studies(Zaratkiewicz, Teegardin et al. 2012, Hampson, Green et al. 2018, Landsperger, Byram et al. 2019, Coyer, Cook et al. 2020, Kuniavsky, Vilenchik et al. 2020) and a meta-analysis (Moser, Peeler et al. 2022) that included many of the studies did not explore undesirable effects associated with using the ETT fixation device. One study reported no significant difference in rates of self-extubation, duration of mechanical ventilation and mortality between groups receiving an ETT securement device versus taping methods.(Landsperger, Byram et al. 2019)
A retrospective observational study (Capasso, Snydeman et al. 2022) conducted in critically ill individuals positioned in prone reported that 20% of individuals experienced a facial pressure injury when the same fixation device was in use. When the proning protocol was adjusted to use of fixation tape for ETTs, there were significantly fewer facial PIs.
4. Overall certainty of evidence: What is the overall certainty of the evidence of effects?
JUDGEMENT
Very low
Low
Moderate
High
No included studies
RESEARCH EVIDENCE
| Outcome | Relative Importance | Certainty of Evidence |
|---|---|---|
| PI occurrence | CRITICAL | VERY LOW |
Outcome 1: PI occurrence
In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical importance (score of 7-9).
The certainty of evidence is very low. The evidence was downgraded twice for risk of bias due all studies having a high or uncertain overall risk of bias.(Moser, Peeler et al. 2022) The evidence was also downgraded due to imprecision and inconsistency.
5. Values:
Is there important uncertainty about or variability in how much people value the main outcomes?
JUDGEMENT
Important uncertainty or variability
Possibly important uncertainty or variability
Probably no important uncertainty or variability
No important uncertainty or variability
RESEARCH EVIDENCE
In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical important (score of 7-9) by all types of stakeholders (health professionals, people with or at risk of a PI and their informal carers, industry representatives and researchers). Greater than 90% of the 158 participants rated this outcome measure as critically important (Lechner, Coleman et al. 2022).
6. Balance of Effects:
Does the balance between desirable and undesirable effects favour the intervention or the comparison?
JUDGEMENT
Favors the comparison
Probably favors the comparison
Does not favor either the intervention or the comparison
Probably favors the intervention
Favors the intervention
Varies
Don’t know
RESEARCH EVIDENCE
There are large desirable effects. Undesirable effects have not been adequately explored, excepting when the individual is in the prone position. In the Guideline Governance Group’s expert opinion, the balance of effects probably favors the intervention, noting that observational studies (Capasso, Snydeman et al. 2022) and consensus guidance (Capasso, Cox et al. 2020, Team, Jones et al. 2022) suggest that commercial fixation device is removed and tape is used to secure the ETT tube when the individual is in the prone position.
7. Resources Required:
How large are resource requirements (costs) of the intervention?
JUDGEMENT
Large costs
Moderate costs
Negligible costs and savings
Moderate savings
Large savings
Varies
Don’t know
RESEARCH EVIDENCE
One of the studies reported that the ETT fixation device required less time to manage than adhesive tape.(Kuniavsky, Vilenchik et al. 2020) ETT fixation devices are likely to be significantly more expensive than adhesive tape. (Moser, Peeler et al. 2022)
8. Certainty of evidence of required resources:
What is the certainty of evidence of resource requirements (costs) of the intervention?
JUDGEMENT
Very low
Low
Moderate
High
No included studies
RESEARCH EVIDENCE
The studies reporting on resource requirements did not explore the associated costs of the intervention in detail.
9. Cost Effectiveness: Does the cost-effectiveness of the intervention favour the intervention or the comparison?
JUDGEMENT
Favors the comparison
Probably favors the comparison
Does not favor either the intervention or the comparison
Probably favors the intervention
Varies
No included studies
RESEARCH EVIDENCE
There are no cost effectiveness evaluations.
10. Inequity:
What would be the impact of recommending the intervention on health inequity?
JUDGEMENT
Reduced
Probably reduced
Probably no impact
Probably increased
Increased
Varies
Don’t know
RESEARCH EVIDENCE
In the Guideline Governance Group’s expert opinion, recommending the use of an ETT securement device is likely to increase health equity because these commercial devices may not be accessible or affordable in all geographic contexts.
11. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
In the Guideline Governance Group’s expert opinion, most stakeholders would accept the use of a securement device.
12. Feasibility:
Is the intervention feasible to implement?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
In one study,(Coyer, Cook et al. 2020) there was issues using the ETT fixation device, primarily related to difficulties applying and securing a preventive dressing underneath the fixation device. In the same study, the ETT fixation device was not repositioned as regularly as required by the study protocol.(Coyer, Cook et al. 2020)
References
Capasso, V., J. Cox, J. Cuddigan, B. Delmore, A. Tescher and S. Solmos (2020). Pressure Injury Prevention: PIP Tips for Prone Positioning, National Pressure Injury Advisory Panel.
Capasso, V., C. Snydeman, K. Miguel, X. Wang, M. Crocker, Z. Chornoby, M. Vangel, M. A. Walsh, J. Murphy and S. Qualls (2022). "Pressure injury development, mitigation, and uutcomes of patients proned for acute respiratory distress syndrome." Adv Skin Wound Care 35(4): 202-212.
Coyer, F., J. L. Cook, W. Brown, A. Vann and A. Doubrovsky (2020). "Securement to prevent device-related pressure injuries in the intensive care unit: A randomised controlled feasibility study." Int Wound J 17(6): 1566-1577.
Hampson, J., C. Green, J. Stewart, L. Armitstead, G. Degan, A. Aubrey, E. Paul and R. Tiruvoipati (2018). "Impact of the introduction of an endotracheal tube attachment device on the incidence and severity of oral pressure injuries in the intensive care unit: a retrospective observational study." BMC Nurs 17: 1-1.
Kuniavsky, M., E. Vilenchik and A. Lubanetz (2020). "Under (less) pressure - Facial pressure ulcer development in ventilated ICU patients: A prospective comparative study comparing two types of endotracheal tube fixations." Intensive & critical care nursing: 102804.
Landsperger, J. S., J. M. Byram, B. D. Lloyd, T. W. Rice and G. Pragmatic Critical Care Research (2019). "The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial." Crit Care 23(1): 161.
Lechner, A., S. Coleman, K. Balzer, J. J. Kirkham, D. Muir, J. Nixon and J. Kottner (2022). "Core outcomes for pressure ulcer prevention trials: results of an international consensus study." Br J Dermatol 187(5): 743-752.
Moser, C. H., A. Peeler, R. Long, B. Schoneboom, C. Budhathoki, P. P. Pelosi, M. J. Brenner and V. Pandian (2022). "Prevention of endotracheal tube-related pressure injury: A systematic review and meta-analysis." Am J Crit Care 31(5): 416-424.
Team, V., A. Jones and C. D. Weller (2022). "Prevention of Hospital-Acquired Pressure Injury in COVID-19 Patients in the Prone Position." Intensive & critical care nursing 68: 103142.
Zaratkiewicz, S., C. Teegardin and J. D. Whitney (2012). "Retrospective review of the reduction of oral pressure ulcers in mechanically ventilated patients: a change in practice." Crit Care Nurs Q 35(3): 247-254.
