Clinical question
Should a fixation device versus no fixation device/tape be used for people at risk of endotracheal tube (ETT)-related pressure injuries?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Conflicts on Interest:
People at risk of device-related pressure injuries (DRPIs)
Any preventive dressing
No preventive dressing
Any clinical setting
Device-related pressure injury
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
Moderate
Don’t know
Very low
No important uncertainty or variability
Probably favors the intervention
Moderate costs
Very low
No included studies
Probably increased
Yes
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 | Preventive dressing |
No preventive dressing |
Difference | Relative effect |
|---|---|---|---|---|
| Reduction in device-related PI occurrence | 99/216 (45.8%) | 112/187 (59.9%) | 180 fewer PIs per 1,000 (from 353 fewer to 120 more) |
RR 0.70 (0.41-1.20) |
Outcome 1: Reduction in DRPI occurrence
The meta-analysis included four randomized controlled trials (RCTs) (Otero, Dominguez et al. 2017, Imbulana, Owen et al. 2018, Chen, Chen et al. 2020, Hashimoto, Sato et al. 2023) that compared using any preventive dressing underneath a medical device to not using a preventive dressing for preventing device-related PIs. The studies explored hydrocolloid dressing applied to children with silicone naso-tracheal tubes, (Chen, Chen et al. 2020) polyurethane foam dressing or 2-layered foam dressing applied to adults with oro-nasal oxygen delivery masks,(Otero, Dominguez et al. 2017) hydrocolloid nasal barrier dressing applied to neonates with binasal continuous positive airway pressure (CPAP) masks,(Imbulana, Owen et al. 2018) and foam surgical tape applied to adults with naso-tracheal tubes.(Hashimoto, Sato et al. 2023)
The meta-analysis showed that using any preventive dressing was associated with a non-significant lower rate of device-related PIs (RR 0.70, 95% CI 0.41 to 1.20, p = 0.20). This translated to a difference of 180 fewer per 1,000 experiencing a device-related PI when a preventive dressing is used. However, the evidence was of very low quality. It is uncertain if the result represents a true effect; the true effect lies between 353 fewer people and 120 more people experiencing a device-related PI with a preventive dressing compared with no preventive dressing.
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
None of the studies reported adverse events as an outcome measure.
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 once for risk of bias due all studies having high or unclear risk of bias.(Patton, Moore et al. 2024) The evidence was also downgraded due to directness due to the wide range of preventive dressings, medical devices and participants. 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
The desirable effects are large, and although the undesirable effects are not reported, the Guideline Governance Group expect that the intervention is probably favored.
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 the average total cost of using a hydrocolloid nasal barrier dressing was $68.65 per infant (Australian dollars, 2018), with dressings remaining in-situ for at least four hours.(Imbulana, Owen et al. 2018) Another study reported the cost of foam surgical tape was approximately 3.6 yen (Japan in 2023), which compared to alternative preventive dressings that ranged from 350 yen to 1000 yen in the same setting.(Hashimoto, Sato et al. 2023)
The Expert Panel Group suggested that in clinical practice, preventive dressings under medical devices may require replacement more frequently due to high levels of moisture, especially for neonates and infants. This may increase the resource requirements.
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 evidence is very of very low certainty. There did not appear to be evaluations of nursing time and other potential resource costs, and the studies were limited to two reports, one specific to infants and one that reported a large cost range for a foam surgical tape intervention.
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 were no identified 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, there is likely to be increased health inequity associated with recommending preventive dressings because the intervention is not universally available across clinical and geographic settings due to access and cost.
11. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
Yes
Varies
Don’t know
RESEARCH EVIDENCE
The Expert Panel Group indicated that preventive dressings under devices is acceptable and common practice.
12. Feasibility:
Is the intervention feasible to implement?
JUDGEMENT
No
Probably no
Probably yes
Yes
Varies
Don’t know
RESEARCH EVIDENCE
Some of the studies explicitly stated that, skin assessment was conducted by viewing the skin under the medical device at least every four hours.(Imbulana, Owen et al. 2018, Chen, Chen et al. 2020) One study indicated that this was feasible because the skin assessment could be conducted at the same time that the medical device was repositioned.(Otero, Dominguez et al. 2017) The Expert Panel Group concurred that preventive dressings are feasible, but ongoing and regular skin assessment must accompany their use.
One study reported that the hydrocolloid preventive dressing used for nasotracheal tubes for children required replacing at least daily, and more frequently with excessive exudate, mucous secretion or perspiration under the dressing.(Chen, Chen et al. 2020) The Expert Panel Group indicated that more frequent replacement is often required due to moisture, especially for neonates and infants.
References
Chen, J., J. Chen, J. Yang, Y. Chen, Y. Liang and Y. Lin (2020). "Investigating the Efficacy of Hydrocolloid Dressing for Preventing Nasotracheal Tube-Related Pressure Injury in the PICU." Pediatric Critical Care Medicine 21(9): e752-e758.
Haesler, E., J. Pittman, J. Cuddigan, S. Law, Y. Y. Chang, K. Balzer, D. Berlowitz, K. Carville, J. Kottner, M. Litchford, Z. Moore, P. Mitchell and D. Sigaudo-Roussel (2022). "An exploration of the perspectives of individuals and their caregivers on pressure ulcer/injury prevention and management to inform the development of a clinical guideline." J Tissue Viability 31(1): 1-10.
Hashimoto, M., A. Sato, Y. Sento, Y. Kamimura, E. Kako, M. Okuda, N. Tachi, Y. Okumura, I. Kuroda, H. Hoshijima, H. Ito and K. Sobue (2023). "3M microfoamTM surgical tape prevents nasal pressure injury associated with nasotracheal intubation: A randomized double-blind trial." Medicine (United States) 102(2): E32679.
Imbulana, D. I., L. S. Owen, J. A. Dawson, J. L. Bailey, P. G. Davis and B. J. Manley (2018). "A Randomized Controlled Trial of a Barrier Dressing to Reduce Nasal Injury in Preterm Infants Receiving Binasal Noninvasive Respiratory Support." J Pediatr 201: 34-39.e33.
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.
Otero, D. P., D. V. Dominguez, L. H. Fernandez, A. S. Magarino, V. J. Gonzalez, J. V. Klepzing and J. V. Montesinos (2017). "Preventing facial pressure ulcers in patients under non-invasive mechanical ventilation: a randomised control trial." J Wound Care 26(3): 128-136.
Patton, D., Z. E. H. Moore, F. Boland, W. P. Chaboyer, S. L. Latimer, R. M. Walker and P. Avsar (2024). "Dressings and topical agents for preventing pressure ulcers." Cochrane Database of Systematic Reviews 12: Art. No. CD009362.
