Background

Early mobility in the intensive care unit is being promoted as a way to improve outcomes but has not been studied in young infants.

Objective

To determine the safety of a holding intervention for infants intubated for respiratory failure.

Methods

Infants less than 6 months of age intubated for respiratory failure underwent a holding intervention in which a caretaker held the infant at least twice a day once the infant was medically stabilized. Rates of adverse events were compared with historical controls matched by age and Pediatric Index of Mortality 2 score. Vital signs before and during holding were recorded to assess for physiologic tolerance.

Results

Twenty-four infants with a total of 158 holding interventions were studied. Mean holding duration was 99 minutes. Twenty holding interventions were terminated early, most commonly because of agitation. The 24 historical controls had 1 unplanned extubation and 2 arterial catheter removals. The intervention group had no unplanned extubations, inadvertent central catheter removals, or urinary catheter removals and had 1 arterial catheter removal that was not associated with holding. Vital signs before and during holding were similar. There were no differences between the control and intervention groups in duration of intubation (7.3 vs 6.0 days, P = .98), length of intensive care unit stay (9.1 vs 9.0 days, P = .52), or length of hospital stay (11.5 vs 12.5 days, P = .28).

Conclusions

Holding intubated infants in the intensive care unit was well tolerated, without an increase in adverse events.

Early physical therapy and ambulation of patients intubated because of respiratory failure has become increasingly popular in adult intensive care units (ICUs) over the last decade. These interventions have been found to decrease sedation needs, shorten the duration of mechanical ventilation and the ICU stay, and improve functional recovery.13  Children are also at risk for adverse outcomes from prolonged immobilization and could therefore benefit from similar mobilization strategies.4  Although more pediatric ICUs are implementing mobility programs, studies on the safety and outcomes of these interventions in children are still limited.5,6 

Barriers for mobilization interventions include concerns for patient safety and medical device removal, lack of resources, and disagreement about when patients are sufficiently stable for a mobility intervention.7  Studies on mobility in the pediatric ICU (PICU) have primarily been in older children who can cooperate with an intervention.6  A significant portion of patients admitted to the PICU are infants who are nonambulatory at baseline, leading care providers to discount the effects of prolonged bed rest, which may include weakness, atelectasis, and ventilator-associated pneumonia, in this population.8 

Infants intubated in the PICU do not have access to their normal calming mechanisms and frequently require sedative infusions to treat agitation and prevent endotracheal tube dislodgment. Increased sedation use has been shown to prolong mechanical ventilation.9  An intervention that could reduce sedation use and promote movement could reduce time in the ICU.

The primary objective of this study was to assess the safety of a holding intervention for young infants intubated for acute respiratory failure. We hypothesized that infants held while intubated would not have an increased rate of adverse events when compared with a control group of infants who were not held. Secondary objectives were associations between infant holding and sedation use, duration of mechanical ventilation, and lengths of PICU and hospital stays.

Methods

Patient Population

This study was approved by the institutional review board at Children’s Mercy Hospital, Kansas City, Missouri. The PICU is a 41-bed mixed unit in a tertiary referral center. Infants less than 6 months of age at the time of admission were eligible for enrollment. Patients were screened daily to identify infants intubated for acute respiratory failure secondary to either viral or bacterial lower respiratory tract disease with an expected duration of mechanical ventilation of greater than 48 hours. Patients were excluded for the following reasons: acute intracranial process in the last 30 days, cyanotic congenital heart disease with baseline arterial oxygen saturation of less than 85%, preadmission diagnosis of pulmonary hypertension, critical airway designation by the PICU attending physician on service, tracheostomy, abdominal surgical procedure during the current admission, ward of the state, extracorporeal membrane oxygenation or continuous renal replacement therapy at the time of screening, and parents/guardians who did not speak English or Spanish.

Children are at risk from prolonged immobilization and could benefit from mobilization strategies.

Study Procedures

The parents/guardians of eligible infants were approached within 48 hours of intubation for consent. This study was not randomized because we believed parents were unlikely to consent to a study in which they could be randomized to not hold their infant. We used the data of patients admitted in the previous 2 years to develop a historical control group with the same inclusion and exclusion criteria, matched 1 to 1 by age and Pediatric Index of Mortality 2 risk of mortality percentage. The PICU standard of care at the time was for intubated infants to remain in bed, and holding was rare. Nurse-to-patient ratios were not different between time periods.

Once enrolled, patients were screened daily to assess whether they met criteria for the intervention that day. To qualify for the intervention the following criteria needed to be met: fraction of inspired oxygen of 0.6 or less, positive end-expiratory pressure of 10 cm H2O or less, peak inspiratory pressure of 30 cm H2O or less, norepinephrine/epinephrine dose of 0.02 μg/kg per minute or less, dopamine dose of 3 μg/kg per minute or less, patient not receiving a vasopressin infusion, neuromuscular blockade infusion turned off for 12 or more hours, inhaled nitric oxide turned off for 12 or more hours, no treatment for arrhythmias in the previous 12 hours, and no chest compressions in the previous 48 hours. These criteria were agreed upon by the PICU physicians to identify infants least likely to suffer serious harm during agitation or endotracheal tube dislodgment. Daily screening continued until discharge from the PICU.

Intervention

On days each patient met intervention criteria the goal was for the infant to be held a minimum of 2 times for at least 1 hour each. The holder could be any family member designated by the parents. If a family member was not available, a nursing or research staff member would hold the infant. The holder remained seated at the side of the crib and transfer was performed by both a nurse and a respiratory therapist. There was no maximum limit to the number of times per day or length of time the infant could be held. The nurse, holder, or physician could terminate the holding before 1 hour for any reason.

Outcomes

The following adverse events were recorded for both the intervention and historical control groups: unplanned extubation, inadvertent central catheter removal, Foley catheter dislodgment, chest tube dislodgment, chest compressions, and death. Patient location and whether the patient was being moved at the time of the adverse event were recorded. Vital signs and State Behavioral Scale score10  before and 20 to 30 minutes after transfer were documented in the intervention group. The State Behavioral Scale is a bedside nursing tool used in the assessment of sedation and agitation in pediatric ICU patients. It is scored from –3 to +2, with a score of 0 indicating an awake and calm infant, negative numbers correlating with increased sedation, and positive numbers correlating with agitation. All of the data were collected prospectively by the bedside nurse, who completed a new data collection sheet for each holding episode. The following secondary outcomes were obtained from the medical records for both groups: duration of mechanical ventilation, lengths of PICU and hospital stays, total doses of sedative and analgesic medications received during the PICU stay, and withdrawal medications being administered upon discharge from the PICU.

Statistics

Univariate comparisons for categorical data were made by using the χ2 test or Fisher exact test as appropriate. Medication doses between groups were compared by using the t test for normally distributed data or the Mann-Whitney U test for nonnormally distributed data. Vital signs before and after the intervention were compared by using the paired t test for normally distributed data or the Wilcoxon signed-rank test for nonnormally distributed data. Ventilator and hospital outcomes are reported as medians (interquartile ranges). All P values are 2 sided, with the level of significance set at less than .05.

Results

From December 14, 2015, through May 30, 2017, a total of 36 intubated infants met the criteria for inclusion. Twelve patients were excluded; the reasons for exclusion are listed in Table 1. The 4 parents declining consent all cited anxiety regarding moving and holding their infants as the reason for not wanting to participate. The remaining 24 infants were enrolled. The mean time from intubation to enrollment was 26 hours (range, 5-69 hours). Baseline demographics for the historical control and intervention groups were similar and are listed in Table 2.

Twenty-three infants were held a total of 158 times. One infant was never held because of resistance from the parent after consent, although this infant was never formally withdrawn from the study. This infant’s data are included in the results. Enrolled infants were eligible for holding on 54% of ventilator days. The goal of holding infants a minimum of 2 times on eligible days was accomplished 64% of the time. A mean of 1.6 holding episodes per infant occurred per eligible day. Individual infants were held a mean of 7 times (range, 0-23 times). The mean length of holding was 99 minutes (range, 1-237 minutes). Twenty holding interventions (12.7%) were terminated before 60 minutes. Reasons for early termination were varied, with agitation being the most commonly cited reason (6 interventions). The mean holding time in the interventions that were ended early was 34 minutes (range, 1-57 minutes).

Records for the historical control group indicated 3 adverse events: 1 unplanned extubation and 2 arterial catheter removals. The intervention group had no unplanned extubations and 1 arterial catheter removal. The catheter removal occurred when the patient was in bed and was not temporally related to holding. No inadvertent central catheter or urinary catheter removals occurred in either group.

Sedative and analgesic drugs administered are reported in Table 3. The number of dexmedetomidine infusions was higher in the intervention group, which also had a higher median total PICU dose of fentanyl. The median total midazolam dose was lower in the intervention group. The need for scheduled medication for drug withdrawal at PICU discharge, also listed in Table 3, was not different between groups.

Vital signs before and during holding were similar (Table 4). Analysis revealed no differences between the control and intervention groups in duration of intubation (median [interquartile range {IQR}]: 7.3 [4.7-9.5] days vs 6.0 [4.8-9.2] days, P = .98), length of PICU stay (median [IQR]: 9.1 [6-12.70] days vs 9.0 [6.5-11.3] days, P = .52), or length of hospital stay (median [IQR]: 11.5 [9.8-19.8] days vs 12.5 [9-15] days, P = .28).

Discussion

In this study, holding infants intubated for primary respiratory failure was safe, with no increased risk of complications. The consent rate was high and infants were frequently held more often and for longer than the minimums stated in the protocol. Vital signs were not different when the infants were being held, showing that the stimulation of being moved and held was physiologically well tolerated. Although this study was not powered to detect differences in outcomes, the results suggest that further research with an expanded patient population would be possible.

Pediatric critical care has had great success in improving patient outcomes. Mortality has become increasingly rare and certain populations will almost always survive, as seen by the less than 1% risk of mortality in our study population. Therefore, the focus of our care is shifting toward limiting morbidity and reducing the long-term adverse effects of critical illness. There is still much work to be done. A multicenter study in the United Kingdom of children discharged from the PICU showed that only one-third were considered in full health 6 months later.4 

The long-term consequences of a PICU stay in an otherwise healthy infant are unknown. In recent years there has been increased concern that many of the sedative medications that are used in the PICU may negatively affect the developing brain.11,12  The environment in the PICU may also cause harm, with disrupted sleep, constant noise and light, and disruption of the normal bonding activities between infant and caregivers.

Neonatal ICUs have led the way in trying to minimize the potential adverse effects of ICU care on infants. For decades parents have been allowed to hold their critically ill newborns in neonatal ICUs. Studies of programs emphasizing developmental care for preterm infants have shown improvements in later neurobehavioral functioning.13,14  Encouraging parents to have a greater involvement in their infants’ care while in the hospital may also reduce parental stress and improve infant outcomes.15  Although older infants being admitted to the ICU for acute illness may have fewer risk factors for poor neurodevelopmental outcome when compared with preterm infants, their brains are still developing rapidly at this age and interventions to lessen the impact of their ICU stay may still be helpful.

Studies of mobility programs in adult ICUs have shown improvements in ventilator time, sedation use, length of stay, and functional outcomes.1,2  These programs are also reported to be safe, with an adverse event rate of less than 1%.16  Pediatric ICUs are beginning to develop mobility programs, although these are largely focused on older children who can cooperate and are at less risk for unplanned extubation.5,17  Holding intubated preterm infants in the neonatal ICU is considered safe,18  but barriers to expanding this practice to older infants remain and include concern for unplanned extubation. In one survey of PICU staff before starting a mobility intervention, only 30% agreed that it was safe to mobilize intubated patients.17 

Our study found few adverse events and no extubations in 158 holding episodes. Although the study protocol stated that infants were to be held for a minimum of 1 hour, half of the holding sessions lasted over 90 minutes, suggesting that they were well tolerated by both the infant and the holder. Nurse staffing and comfort with the intervention were initial barriers to holding infants. At the time of study initiation, intubated infants were rarely held in our PICU. By study completion, this practice had expanded to a wide variety of other critically ill infants, including newborns who had undergone surgical procedures for complex congenital heart disease. Although effects on parents were not examined in this study, nurses reported that the biggest impact of the study appeared to be to the parents’ moods, which led nurses to encourage holding by parents outside the study protocol. Further studies investigating levels of anxiety and posttraumatic stress disorder in parents who are allowed greater contact with their critically ill infants would be interesting.

This study was limited by a small sample size. We chose infants intubated for primary respiratory failure because of this population’s low baseline risk of morbidity and mortality. According to the Pediatric Index of Mortality 2, our cohort’s risk of mortality was 0.6%.19  These results cannot necessarily be applied to infants with greater derangements in their physiology. Further studies in higher-acuity populations are warranted before holding can be declared safe for these infants. This study was also not powered to detect differences in hospital outcomes, given the large number of patients that would be needed for such a study. We felt that randomization was not feasible, so we used a historical control group. The use of a historical control group limits the type of data that can be obtained from the medical records and risks missing events that were not documented.

Encouraging parents to have greater involvement in their infants’ care while in the hospital may reduce parental stress.

Sedative use was significantly different between the control and intervention groups, but this likely has more to do with changes in sedation practices during the study time frame than with the holding intervention. Dexmedetomidine has become increasingly popular nationwide as a replacement for benzodiazepines20  and this change is evident in our data. Although our hope is that infants being held would require less sedation to remain comfortable, we can make no conclusions based on this data and there is a possibility that nurses would sedate infants more during holding out of fear of unplanned extubation.

Conclusions

Holding infants intubated for primary respiratory failure was safe, with no unplanned extubations and no changes in vital signs. The intervention was well received by nurses and parents and led to an unexpected increase in holding for all infant populations in our PICU. Further studies should focus on both infant and parental outcomes.

Acknowledgments

All study procedures were performed in the PICU at Children’s Mercy Hospital, Kansas City, Missouri. We would like to express our gratitude to the PICU nurses at Children’s Mercy Hospital for their participation and to Amber Hughes-Schalk for data collection.

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Footnotes

To purchase electronic or print reprints, contact the American Association of Critical-Care Nurses, 101 Columbia, Aliso Viejo, CA 92656. Phone, (800) 899-1712 or (949) 362-2050 (ext 532); fax, (949) 362-2049; email, reprints@aacn.org.

 

Financial Disclosures

Funding was provided by the Department of Pediatrics of Children’s Mercy Hospital.

 

See Also

To learn more about pediatric care in the critical care setting, read “Improving Collaborative Decision-making in the Pediatric Setting” by Small in AACN Advanced Critical Care, Summer 2019;30:189-192. Available at www.aacnacconline.org.