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CE Article

Influence of Physical Restraint on Unplanned Extubation of Adult Intensive Care Patients: A Case-Control Study

Corresponding author: Yann-Fen Chao, RN, PhD, College of Nursing, Taipei Medical University, 250 Wu-Xin St, Taipei City, Taiwan 110 (e-mail: yfchao.tw{at}yahoo.com.tw).

	Abstract

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Background Unplanned extubation commonly occurs in intensive care units. Various physical restraints have been used to prevent patients from removing their endotracheal tubes. However, physical restraint not only does not consistently prevent injury but also may be a safety hazard to patients.

Objectives To evaluate the effect of physical restraint on unplanned extubation in adult intensive care patients.

Methods A total of 100 patients with unplanned extubations and 200 age-, sex-, and diagnosis-matched controls with no record of unplanned extubation were included in this case-control study. The 300 participants were selected from a population of 1455 patients receiving mechanical ventilation during a 21-month period in an adult intensive care unit at a medical center in Taiwan. Data were collected by reviewing medical records and incident reports of unplanned extubation.

Results The incidence rate of unplanned extubation was 8.7%. Factors associated with increased risk for unplanned extubation included use of physical restraints (increased risk, 3.11 times), nosocomial infection (increased risk, 2.02 times), and a score of 9 or greater on the Glasgow Coma Scale on admission to the unit (increased risk, 1.98 times). Episodes of unplanned extubation also were associated with longer stays in the unit.

Conclusions An impaired level of consciousness on admission to the intensive care unit and the presence of nosocomial infection intensify the risk for unplanned extubation, even when physical restraints are used. To minimize the risk of unplanned extubation, nurses must establish better standards for using restraints.

Notice to CE enrollees: A closed-book, multiple-choice examination following this article tests your understanding of the following objectives: Describe the role of physical restraint in unplanned extubation. Recognize nursing- and patient-related factors that increase the risk of extubation. Review the study presented to evaluate its usefulness for clinical practice. To read this article and take the CE test online, visit www.ajcconline.org and click "CE Articles in This Issue." No CE test fee for AACN members.

	Literature Review

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Risk factors associated with unplanned extubation include both patient- and nursing-related factors. Risk factors related to patients include restlessness, agitation, confusion, physical suffering, nosocomial infection, and oral (vs nasotracheal) intubation.^1,4,6 Risk factors related to nursing include poor fixation of the endotracheal tube,⁷ high patient-to-nurse ratios, and the night shift.^3,8

Unplanned extubation of patients who require mechanical ventilation can be life-threatening; the most serious consequences are cardiopulmonary arrest and death.² The reported reintubation rates after unplanned extubation are 36% to 57% for the first hour^9–11 and 37% to 57% within 48 hours.^3,6,12,13 Replacement of the endotracheal tube often can lead to hemodynamic and airway complications.¹⁴ Unplanned extubation and reintubation are associated with longer total duration of mechanical ventilation, ICU stay, and hospital stay.^6,12 Prevention of unplanned extubation remains an important issue in critical care.

Problems with unplanned extubation in ICUs can be handled with or without restraints. Some investigators^15,16 have suggested that restraining an unconscious or restless patient might prevent self-extubation, whereas other researchers¹⁷ are concerned that use of restraints might cause anxiety and increase the possibility of unplanned extubation. Nevertheless, self-extubation occurs despite the use of sedation and restraints. The reported percentage of unplanned extubations initiated by restrained patients varies widely, from 25.6% to 80%.^1,3,18

The incidence of unplanned extubation ranges from 3.4% to 22.5%.

 

Sedation, a chemical form of restraint, has been proposed to decrease the incidence of unplanned extubation. However, sedation increases the risk for unplanned extubation by prolonging mechanical ventilation and initiating paradoxical agitation.⁴ Physical restraints remain the first choice when unplanned extubation is considered a high risk. The inconsistent effect of physical restraints on preventing unplanned extubation^15–17 is confusing for clinicians. Evidence is required to guide the decision about whether or not to use physical or chemical restraints to decrease unplanned extubation.

	Purpose

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The relationship between unplanned extubation and physical restraints may differ in various settings. We conducted this retrospective study to analyze risk factors and explore the influence of physical restraints on unplanned extubation. The aims of the study were to (1) identify the factors associated with increased risk for unplanned extubation and (2) determine the risk factors for unplanned extubation in patients with and without physical restraints.

Self-extubation occurs despite the use of sedation and restraints.

 

	Methods

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Design and Sample
This retrospective, case-controlled study was conducted in a 42-bed, open-room setting, adult ICU at Taichung Veterans General Hospital, Taichung, Taiwan, Republic of China. The mean number of years that nursing staff had worked in the ICU was 4.85 (SD, 3.73; range, 2–19). The study population included all patients who were admitted and intubated in this adult ICU during a 21-month period (between October 2003 and July 2005). The unplanned extubation group consisted of 100 patients receiving mechanical ventilation who had an unplanned extubation; the control group consisted of 200 patients receiving mechanical ventilation who had no record of unplanned extubation.

In order to increase the statistical power of the study, 2 control patients were selected for each patient who had an unplanned extubation.¹⁹ Case matching was based on each patient’s age, sex, diagnosis, and dates of hospital stay. The incidence rate of unplanned extubation was calculated as follows: [(total number of patients with unplanned extubation)/(total number of intubated patients)] x 100. The incidence density of unplanned extubation was calculated as [(total number of patients with unplanned extubation)/(total number of days of mechanical ventilation)] x 100.

Data Collection
Data were collected by reviewing medical records and incident reports of unplanned extubations and completing a structured data collection sheet. Data included patients’ demographics, admission diagnosis, score on the Acute Physiological and Chronic Health Evaluation (APACHE) II, total length of ICU/hospital stay, and the following data related to the unplanned extubation: consciousness status, days of mechanical ventilation, ventilation parameters, presence of nosocomial infection, use of sedation, and use of physical restraint. The information on nosocomial infection was offered by the infection control committee and was based on the standard of the Centers for Disease Control and Prevention.²⁰ In this study, sedatives were drugs used to modify behavior, including hypnotic agents (propofol or etomidate) and non-depolarizing muscle relaxants.

The unplanned extubation group had better GCS scores on admission, more nosocomial infections, and higher use of physical restraints.

 

Ethical Considerations
The study was approved by the ethical review board of the hospital. The standard protocol for physical restraint in this unit was (1) an evaluation of the risk of unplanned extubation and/or fall, with a physician explaining the necessity of physical restraint to the patient and the patient’s family; (2) after obtaining the written medical order and getting the informed consent form signed by the patient or the patient’s family member, the nurse restraining the patient with a proper device; (3) at 2-hour intervals, the nurse removing the physical restraint, performing a massage and range-of-motion exercises on the restrained joints, and documenting observations of the restrained area.

Data Analysis
Data were analyzed by using SPSS software (version 12.0 for PC, SPSS Inc, Chicago, Illinois). The major statistical procedures used in this study were ² test, risk estimation, Mann-Whitney test, t test, receiver-operating-characteristic curve analysis, and logistic regression. A power analysis based on the effect size of the data indicated that the sample size had a power greater than 90% at the significance level of .05 for the ² test, t test, and regression analysis.

	Results

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Incidence Rate of Unplanned Extubation
In a 21-month period, 126 episodes of unplanned extubation occurred in 1455 patients receiving mechanical ventilation. The incidence rate of unplanned extubation was 8.7% and the incidence density of unplanned extubation was 2.07%. Patients in the unplanned extubation group had diagnoses of pneumonia (37.5%), chronic obstructive pulmonary disease (21.5%), substance intoxication (14%), and cancer (6%). The mean duration of mechanical ventilation before unplanned extubation was 8.6 days (SD, 7.4); 14% of such extubations occurred on the first day, 54% within the first 7 days, and 79% within the first 14 days. The mean score on the Glasgow Coma Scale (GCS) at the time of unplanned extubation was 10.6 (SD, 0.8).

A total of 68 patients were reintubated. The main reason for reintubation was respiratory distress (63 patients). The remaining 5 patients were reintubated because of poor cough ability. Among the 68 patients, 55 were reintubated within 1 hour. From the 126 patients who had an unplanned extubation, we selected the 100 patients who had their first and only unplanned extubation and finished their ICU stay during our study period as the unplanned extubation group. A total of 200 patients from the same population matched for age, sex, diagnosis, and duration of ICU stay who had no record of unplanned extubation were used as the control group.

The characteristics of the unplanned extubation and control groups are listed in Table 1. The mean APACHE II scores were 21.2 (SD, 7.5; range, 3–63) for the unplanned extubation group and 22.4 (SD, 7.3; range, 6–44) for the control group. No significant differences were apparent in age, sex, APACHE II scores, route of intubation, and sedative status between the 2 groups. The unplanned extubation group had better GCS scores on admission (mean [SD], 10.1 [2.2] vs 9.2 [3.0], P = .002), higher rates of nosocomial infection (26.0% vs 12.5%, P = .004), and higher rates of use of physical restraint (82.0% vs 54.5%, P < .001). The types of nosocomial infection did not differ significantly in frequency between groups (P = .29). The unplanned extubation group also had a longer ICU stay than did the control group (mean [SD], 22.9 [16.4] vs 16.5 [13.3], P = .001).

The risk of unplanned extubation is increased 1.98 times with a GCS score of 9 or greater.

 

Multivariate Risk Estimate of Unplanned Extubation
A forward logistic regression model was used to examine the summative risk of the occurrence of unplanned extubation. The variable selected first was physical restraint, next was presence of nosocomial infection, and the last was GCS score on ICU admission. A receiver-operating-characteristic curve procedure was applied to examine the best cutoff point of the GCS score for predicting unplanned extubation. A GCS score of 9 had a sensitivity of 85.0% and a specificity of 80.8%. Physical restraint, presence of nosocomial infection, and GCS score of 9 were entered in a logistic regression procedure again; the results are summarized in Table 4. The overall accuracy rate of this model was 69%. From the model, the relative risk of a patient with a GCS score of 9 for an unplanned extubation was 1.98. If physical restraint was used on such a patient, the risk of unplanned extubation increased to 6.16 (1.98 x 3.11). If the presence of nosocomial infection was added, then the risk of unplanned extubation increased to 12.44 (1.98 x 3.11 x 2.02). The cumulative risk of various combination situations is illustrated in the Figure.

View larger version (39K): [in this window] [in a new window]   Figure Cumulative risk of unplanned extubation at various multivariate levels.

	Discussion

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In our study, the mean duration of intubation before unplanned extubation was 8.6 (SD, 7.4) days, and 54% of unplanned extubations occurred in the first 7 days. These findings are similar to that in the study by Pesiri et al,¹⁵ in which 60% of unplanned extubations occurred within 7 days of intubation.

We matched the unplanned extubation group and the control group by age, sex, diagnosis, and duration of hospitalization; no significant difference in these variables was expected. The APACHE II scores of the 2 groups were similar. Therefore, the severity of patients’ conditions had similar effects on the results in the 2 groups. However, the unplanned extubation group had significantly better GCS scores, as well as higher rates of use of physical restraint and nosocomial infection, than did the control group (Table 1). These 3 variables (level of consciousness, use of physical restraints, and development of infection) were also significant predictors of unplanned extubation according to multivariate logistic regression (Table 4).

Influence of Physical Restraints on Patients Who Had Unplanned Extubation
In this study, 82% of unplanned extubations occurred in patients with physical restraints. This finding is similar to the results of other studies,^1,3 which indicate that use of physical restraint not only is inadequate in preventing unplanned extubation but actually promotes unplanned extubation. Because the GCS scores and rates of nosocomial infection were higher in physically restrained subjects (Table 2), it seems likely that patients who had a higher level of consciousness and also had a nosocomial infection had higher rates of being physically restrained, and the 3 risk factors tended to aggregate and led to unplanned extubation. However, GCS scores did not differ significantly between the unplanned extubation group and the control group if the patients were physically restrained, and infection rates did not differ significantly between the unplanned extubation group and the control group if the subjects were not physically restrained (Table 3). These results indicate that physically restrained patients with nosocomial infection and patients with better neurological status who are not physically restrained are most at risk for unplanned extubation. In other words, the risk of unplanned extubation can be due to the use of physical restraints and the presence of nosocomial infection.

Similarly, the risk of unplanned extubation is greater when the patient is not under physical restraint and the patient’s GCS score on ICU admission is 9 or greater. Patients with better GCS scores are more responsive to sensory stimuli. This greater responsiveness may explain the increased risk of unplanned extubation in patients with GCS scores of 9 or more. Therefore, physical restraint should be applied only when it is essential to a patient’s safety or chemical restraint (sedative therapy) is not appropriate. When such a situation occurs, nurses must develop a better way of physically restraining patients, taking patients’ safety, comfort, and potential adverse outcomes into consideration. Currently, use of a wrist belt tied to the bedside railing is the most common method of restraining patients.

Unplanned extubation usually occurs when a patient moves his or her hand to reach and pull out the tube. A 30° elevation of the head of the bed is common to avoid aspiration and promote ventilation²¹; however, such elevation increases the chance of unplanned extubation. Researchers have suggested that a patient’s hands should be kept at least 20 cm away from the tubes,²² and avoiding the head-up position might prevent unplanned extubation.²³ More investigations are needed to develop better appliances and methods for physical restraint.

Clinical Implications
The Figure summarizes the risk of unplanned extubation. These results may help remind nurses about the risks involved when physical restraints are used in the ICU. The precautions against unplanned extubation begin when a patient is admitted to the ICU. A GCS score of 9 or greater is associated with a risk of unplanned extubation of 1.98. The use of physical restraints to address agitation or for any other reason requires careful evaluation, because use of physical restraint increases the risk for unplanned extubation by 3.11 times, and the risk increases to 12.44 times if a nosocomial infection is also present. Without physical restraints, the risk of unplanned extubation in a patient with a GCS score of 9 or greater on ICU admission who has an infection is only 4.00 times greater than the risk in a patient with a GCS score less than 9 and no nosocomial infection. In our study, patients with an infection had a higher risk (odds ratio, 2.71; 95% confidence interval, 1.29–5.65) of being restrained (Table 2). Caution is needed when the use of physical restraint is being considered. Initiation of physical restraint on a patient with an infection will increase the risk of unplanned extubation up to 6.28 times, which is much higher than the risk of unplanned extubation in a patient with only an infection (2.02 times).

Limitation of the Study
In this study, data were obtained by reviewing the medical charts and incident reports. We assumed that the data were documented accurately and adequately. Our findings may be biased because of selective deposit and selective survival, which are common in studies that use existing data. Therefore, further investigation is necessary.

	Conclusions

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A GCS score of 9 or greater on ICU admission increases the risk of unplanned extubation. Patients are more likely to have an unplanned extubation when they are physically restrained. The risk becomes higher in the presence of nosocomial infection. To minimize the risk of unplanned extubation, nurses must assess patients’ GCS status and evaluate the risk of applying physical restraint. To promote patients’ safety, we must develop effective standards for use of physical restraints so that we can prevent unplanned extubation.

	ACKNOWLEDGMENTS

 
Appreciation is extended to all the participating administrators, staff, and patients at the Taichung Veterans General Hospital whose support made this study possible.

To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. Phone, (800) 809-2273 or (949) 362-2050 (ext 532); fax, (949) 362-2049; e-mail, reprints{at}aacn.org.

FINANCIAL DISCLOSURES
This research was supported by grants from the Taichung Veterans General Hospital Research Program (TCVGH-917412A).

eLetters
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SEE ALSO
To learn more about unplanned extubations, visit www.ajcconline.org and read the article by Curry and colleagues, "Characteristics Associated With Unplanned Extubations in a Surgical Intensive Care Unit" (Am J Crit Care, January 2008).

	REFERENCES

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