Pressure ulcers in critically ill patients – Preventable by non-sedation? A substudy of the NONSEDA-trial

doi:10.1016/j.iccn.2017.09.005

Intensive and Critical Care Nursing

Volume 44, February 2018, Pages 31-35

https://doi.org/10.1016/j.iccn.2017.09.005 Get rights and content

Abstract

Objective

Pressure ulcers still pose a significant clinical challenge to critically ill patients. This study is a substudy of the multicenter NONSEDA-trial, where critically ill patients were randomised to sedation or non-sedation during mechanical ventilation. The objective of this substudy was to assess if non-sedation affected the occurrence of pressure ulcers.

Design

Retrospective assessment of data from a single NONSEDA-trial site.

Setting

Mixed intensive care unit.

Outcome measures

The occurrence of pressure ulcers, described by grade and location.

Results

205 patients were included. Patients with pressure ulcers in the two groups were comparable with regards to baseline data. There were 44 ulcers in 32 patients in the sedated group and 31 ulcers in 25 patients in the non-sedated group (p = 0.08). 64% of the ulcers in sedated patients were located on sacrum and heels, whereas 68% of the ulcers in non-sedated patients were related to equipment (p = 0.03).

Conclusions

Non-sedation did not significantly reduce the number of pressure ulcers. Non-sedation significantly affected the location of ulcers: non-sedated patients mainly had ulcers related to equipment, whereas sedated patients mainly had ulcers on the sacrum and heels.

Introduction

A pressure ulcer is a localised injury to the skin, the underlying tissue or both, usually over a bony prominence, developing as a result of pressure or pressure in combination with shear (Cooper et al., 2015, Hoogendoorn et al., 2017; National Pressure Ulcer Advisory Panel et al., 2014). Pressure ulcers are graded 1–4 according to severity, 4 being the worst (Grey et al., 2006, National Pressure Ulcer Advisory Panel et al., 2014). Despite major refinements within medical technology and intensive care nursing during the past decades, pressure ulcers continue to be a highly relevant clinical challenge. The prevalence of pressure ulcers in intensive care unit (ICU) patients ranges from 14 to 56% (Keller et al., 2002, Cooper, 2013) (medical and surgical ICU-patients). Consensus is that most, but not all pressure ulcers are preventable and that it is a multifactorial problem (Black et al., 2011). ICU-patients face many of the risk factors for developing pressure ulcers, such as long-term immobility, haemodynamic instability and subsequent use of vasopressors, nutritional deficiencies, decreased consciousness leading to a loss of sensory perception or decreased ability to react appropriately in response to discomfort (Cooper, 2013). This can have dire consequences, since pressure ulcers cause great discomfort, increase the patients’ risk of serious infections, are associated with increased length of stay in hospital and with increased mortality (Graves et al., 2005, Redelings et al., 2005, Grey et al., 2006). The economic issues related to pressure ulcers are also considerable. The annual cost of pressure ulcer care in the United Kingdom (UK) has been estimated to be as high as two billion pounds (McBride and Richardson, 2015, Grey et al., 2006). A recent systematic review, including more than 19.000 patients admitted to intensive care units, identified sedation as one of the major risk factors for the development of pressure ulcers (Serranoa et al., 2017).

This study is nested within the NONSEDA-trial, a randomised multicenter trial. Patients in seven ICU’s in Denmark, Sweden and Norway were randomised to either usual care of sedation with a daily wake-up attempt or to non-sedation with sufficient pain management (Toft et al., 2014). This trial comprises data from a single trial-site subpopulation of the NONSEDA-trial. Through clinical experience with both sedated and non-sedated patients, we noticed that non-sedated patients seemed to change position in bed more often and were easier mobilised. We therefore hypothesised that non-sedation decreases the occurrence of pressure ulcers. The aim of this substudy of the NONSEDA-trial was to assess whether non-sedation affects the occurrence of pressure ulcers.

Section snippets

Methods

The NONSEDA-trial is a multicenter, randomised trial, taking place in seven ICUs in Denmark, Sweden and Norway. It is designed to include 700 mechanically ventilated, adult (age 18 or above) patients (some sites are still including patients per October 2017, where 680 patients have been included). This substudy of the NONSEDA-trial comprises data from a predefined subpopulation of 200 NONSEDA-patients. These patients were all included, stratified, randomised and treated in a single

Results

A total of 205 patients were included from January 2014 to January 2017. We found no significant differences between the patients who developed pressure ulcers within the two groups regarding baseline characteristics (Table 1). The length of stay in the ICU was a median of 18 days (IQR 9–31) for the whole sample of patients with ulcers, with no significant difference between groups (p = 0.22). There was no significant difference in the number of pressure ulcers in the two groups (Table 2, p = 0.08).

Discussion

We found a tendency towards fewer and more superficial ulcers in the non-sedated patients, however this was not significant. The location of the pressure ulcers was found to be significantly different in the two groups. Pressure ulcers normally develop most frequently on the lower half of the body (Grey et al., 2006). The sedated patients had more ulcers in these “classic” locations, on the sacrum and heels, whereas the non-sedated predominantly had ulcers related to equipment, tubes and

Limitations

There are limitations to this study. The study was not designed for the assessment of pressure ulcers, and no specific sample size calculation was performed. It is a single-site study (for practical and economic reasons). Data were collected retrospectively. Furthermore, we had to rely completely on the registration performed by the treating staff, regardless of their level of training concerning pressure ulcers.

Conclusion

In conclusion, non-sedation in this patient population did not significantly prevent pressure ulcers, however a trend towards fewer and more superficial pressure ulcers in the non-sedated patients was seen. Sedated patients mainly had ulcers on the heels and sacrum, whereas non-sedated patients predominantly had ulcers related to equipment, which might have a better prognosis for healing. If using sedation for critically ill patients, extra attention is needed to prevent the classic pressure

Financial support

This study has been conducted as a part of Helene K. Nedergaard’s PhD-thesis, which is funded by University of Southern Denmark, The Strategic Research Council, The Scandinavian Society of Anaesthesiology and Intensive Care and the Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, Kolding, Denmark.

Clinical trial information

The NONSEDA trial was approved by the local Scientific Research Ethics Committee for the Region of Southern Denmark and registered at clinicaltrials.gov (NCT 01967680). Informed consent was obtained from all participants in the study, either from the patients themselves, or in case of impaired consciousness, from the patient’s closest relative and the general practitioner. The study was registered with the Danish Data Protection Agency.

Ethical statement

Concerning the manuscript entitled: Pressure ulcers in critically ill patients – preventable by non-sedation?

Conflicts of interest

All authors declare that we have no conflicts of interests.

Acknowledgment

We thank René DePont Christensen, statistician, for invaluable help with the statistical plan and analyses.

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Pressure injuries occur in ICU patients due to multiple comorbidities, acute clinical conditions, and ICU treatments (Labeau et al., 2021; Sala et al., 2021; Lin et al., 2021). Pressure injury more frequently affects those with acute organ derangements such as cardiovascular instability requiring vasopressor agents and acute respiratory failure requiring invasive mechanical ventilation and sedation, analgesia, and/or neuromuscular blockade agents (Nedergaard et al., 2018). Critical illness also threatens skin integrity by systemic inflammation and associated catabolic processes triggering muscle wasting and weight loss.
Pressure injuries are a frequent complication in intensive care unit (ICU) patients, especially in those with comorbid conditions such as chronic obstructive pulmonary disease (COPD). Yet no epidemiological data on pressure injuries in critically ill COPD patients are available.
To assess the prevalence of ICU-acquired pressure injuries in critically ill COPD patients and to investigate associations between COPD status, presence of ICU-acquired pressure injury, and mortality.
This is a secondary analysis of prospectively collected data from DecubICUs, a multinational one-day point-prevalence study of pressure injuries in adult ICU patients. We generated a propensity score summarizing risk for COPD and ICU-acquired pressure injury. The propensity score was used as matching criterion (1:1-ratio) to assess the proportion of ICU-acquired pressure injury attributable to COPD. The propensity score was then used in regression modeling assessing the association of COPD with risk of ICU-acquired pressure injury, and examining variables associated with mortality (Cox proportional-hazard regression).
Of the 13,254 patients recruited to DecubICUs, 1663 (12.5%) had documented COPD. ICU-acquired pressure injury prevalence was higher in COPD patients: 22.1% (95% confidence interval [CI] 20.2 to 24.2) vs. 15.3% (95% CI 14.7 to 16.0). COPD was independently associated with developing ICU-acquired pressure injury (odds ratio 1.40, 95% CI 1.23 to 1.61); the proportion attributable to COPD was 6.4% (95% CI 5.2 to 7.6). Compared with non-COPD patients without pressure injury, mortality was no different among patients without COPD but with pressure injury (hazard ratio [HR] 1.07, 95% CI 0.97 to 1.17) or COPD patients without pressure injury (HR 1.13, 95% CI 1.00 to 1.27). Mortality was higher among COPD patients with pressure injury (HR 1.35, 95% CI 1.15 to 1.58).
Critically ill COPD patients have a statistically significant higher risk of pressure injury. Moreover, those that develop pressure injury are at higher risk of mortality. As such, pressure injury may serve as a surrogate for poor prognostic status to help clinicians identify patients at high risk of death. Also, delivery of interventions to prevent pressure injury are paramount in critically ill COPD patients. Further studies should determine if early intervention in critically ill COPD patients can modify development of pressure injury and improve prognosis.
Is there a relationship between nutritional goal achievement and pressure injury risk in intensive care unit patients receiving enteral nutrition?
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Pressure injuries (PI) are characterised by skin damage and either soft tissues resulting from compression of the bony prominence against a hard surface or related to medical device (NPUAP, 2016). The development of PI has been related to mortality, morbidity and high costs and is one of the most frequent potentially preventable adverse events (Chaboyer et al., 2018; Llaurado-Sera and Afonso, 2018; Nedergaard et al, 2018). The PI rate has been an indicator of both quality of care and patient’s safety (de Almeida Medeiros et al., 2018).
To assess pressure injury risk and time until pressure injury development according to the achievement of nutritional goals, i.e. caloric and protein intake within the first 72 hours of the intensive care admission.
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The study sample included 181 patients, of which 56.4% were male and the average age was 55 years. Neurological pathologies were the most frequent cause of hospitalisation (44.8%). The average length of stay was 17.5 days and mortality 30.4%. With regards to nutritional goals, 105 patients (58.0%) achieved their caloric goal, 130 (71.8%) achieved protein goals, and 98 (54.1%) achieved both. The frequency of pressure injury occurrence was 31.5%. Caloric intake (hazard ratio [HR] 2.3, 95% confidence interval [CI] 1.24-4.36) and protein intake (HR 3.21, 95% CI 1.76-5.86), were identified as independently associated with pressure injury development. Higher Braden scores were identified as a protective factor (HR 0.65, 95% CI 0.56-0.77).
These results indicate that the time to pressure injury development in the group of patients who did not achieve nutritional goals was shorter compared to those who achieved nutritional goals. Further studies should be conducted to confirm these data and to study the relationships in greater detail.
Oral mucosa pressure ulcers in intensive care unit patients: A preliminary observational study of incidence and risk factors
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Non-sedated patients are able to change position in bed in response to discomfort, which is important for preventing traditional PUs. However, they had a higher rate of device-related PUs because equipment can move due to their movements, causing pressure or friction, which may not be noticed or difficult to re-adjust [33]. Patients in this study were not completely awake, based on the sedation score; they might bite their bite-block or commercial ETT holder with greater power due to discomfort and cause pressure or rub on the lower oral mucosa.
Purpose: This study examined the incidence of oral mucosa pressure ulcers (PUs) in intensive care unit (ICU) patients and the relationship between biomechanical and physiological variables in onset of PUs. Methods: A prospective observational descriptive study design was used. We recruited patients over 18 years of age with endotracheal tube (ETT) insertion in three ICUs in a tertiary hospital in Korea. We analysed 113 patient-days of data. Patient assessments and medical record reviews were conducted to gather biomechanical and physiological data. Fisher's exact tests and χ² test and Spearman's rank correlations were used to compare data. Results: The highest incidence of oral mucosa PUs occurred in lower oral mucosa (36.3%). There was a significant relationship between lower oral mucosa PU stage and bite-block or airway use (r = .20, p = .036), commercial ETT holder use (r = 0.19, p = .048), sedative use (r = −0.22, p = .022), and plasma protein (r = 0.20, p = .033). Upper oral mucosa PU stage was related to commercial ETT holder use (r = 0.19, p = .044), haemoglobin(r = 0.24, p = .011), haematocrit (r = 0.27, p = .004), and serum albumin (r = −0.24, p = .012). Stage was related to commercial ETT holder use in both sites (r = 0.28, p = .003), haematocrit (r = 0.19, p = .039), and serum albumin (r = −0.23, p = .015). Conclusion: Oral mucosa PUs developed more frequently and healed more quickly than general skin PUs. Taken together, these data indicate that biomechanical and haematological variables are risk factors associated with PU incidence should be considered in intensive care patients.

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Research articlePressure ulcers in critically ill patients – Preventable by non-sedation? A substudy of the NONSEDA-trial

Abstract

Objective

Design

Setting

Outcome measures

Results

Conclusions

Introduction

Section snippets

Methods

Results

Discussion

Limitations

Conclusion

Financial support

Clinical trial information

Ethical statement

Conflicts of interest

Acknowledgment

J. Tissue Viability

Pressure ulcers: avoidable or unavoidable? Results of the national pressure ulcer advisory panel consensus cenference

Ostomy Wound Manage.

The prevention and management of pressure ulcers: summary of updated NICE guidance

J. Wound Care

Evidence-based prevention of pressure ulcers in the intensive care unit

Crit. Care Nurs.

Effect of pressure ulcers on length of hospital stay

Infect. Control Hosp. Epidemiol.

Pressure ulcers

Br. Med. J.

Sepsis-associated encephalopathy and its differential diagnosis

Crit. Care Med.

Research article
Pressure ulcers in critically ill patients – Preventable by non-sedation? A substudy of the NONSEDA-trial