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* From the Department of Pediatrics (Drs. Meert and Daphtary), Childrens Hospital of Michigan, Wayne State University School of Medicine, Detroit, MI; and St. Louis University School of Nursing (Dr. Metheny), St. Louis, MO.
Correspondence to: Kathleen L. Meert, MD, Critical Care Medicine, Childrens Hospital of Michigan, 3901 Beaubien Blvd, Detroit, MI 48201; e-mail: kmeert{at}med.wayne.edu
| Abstract |
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Design: Randomized controlled trial.
Setting: Pediatric ICU in a university teaching hospital.
Patients: Seventy-four critically ill patients < 18 years of age receiving mechanical ventilation were randomized to receive gastric or small-bowel feeding.
Interventions: All feeding tubes were inserted at the bedside. Color, pH, and bilirubin concentration of the feeding tube aspirates were used to guide placement. Final tube position was confirmed radiographically. Continuous feedings were advanced to achieve a caloric goal based on age and body weight. Tracheal secretions were collected daily and tested for gastric pepsin by immunoassay.
Measurements and results: Thirty-two patients were randomized to the gastric group, and 42 patients were randomized to the small-bowel group. Twelve patients exited the study because a small-bowel tube could not be placed at the bedside, leaving 30 patients in the small-bowel group. Gastric and small-bowel groups were similar at baseline in age, sex, percentage of ideal body weight, serum prealbumin concentration, and pediatric risk of mortality score. The percentage of daily caloric goal achieved was less in the gastric group compared to the small-bowel group (30 ± 23% vs 47 ± 22%, p < 0.01). No difference was found in the proportion of tracheal aspirates positive for pepsin between the gastric and small-bowel groups (50 of 146 aspirates vs 50 of 172 aspirates, respectively; p = 0.3). No differences were found in the frequency of feeding tube displacement, abdominal distension, vomiting, or diarrhea between groups.
Conclusions: Small-bowel feeds allow a greater amount of nutrition to be successfully delivered to critically ill children. Small-bowel feeds do not prevent aspiration of gastric contents.
Key Words: adolescent aspiration child child, preschool critical care enteral nutrition infant randomized controlled trial
| Introduction |
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Enteral feeds may be delivered into the stomach or the small bowel depending on the position of the feeding tube within the GI tract. Whether feeding into the small bowel alters the incidence of aspiration remains controversial. Previous randomized trials678910111213 in critically ill adults have yielded conflicting results. Using radioisotope labeled feeds, Heyland et al9 demonstrated that gastric-fed patients had more episodes of gastroesophageal regurgitation and a trend toward more microaspiration than patients fed beyond the pylorus. Other investigators67101112 have been unable to show a difference in the rates of aspiration and/or pneumonia between gastric and small-bowelfed patients, when a combination of clinical and radiographic criteria was used for diagnosis. Similar controversy exists with regard to feeding tolerance and the achievement of nutritional goals. Neumann and DeLegge6 showed that gastric-fed patients achieved their feeding goal sooner than patients fed via the small bowel. However, others8101113 have suggested that a greater percentage of the caloric goal can be achieved by the small-bowel route. A recent metaanalysis14 of adult trials was unable to demonstrate any clinical benefit to small-bowel feeding compared to gastric feeding.
Placement of a small-bowel feeding tube may be difficult to accomplish at the bedside. A variety of techniques for placing tubes beyond the pylorus have been described including the use of stylets, weighted tube tips, magnets, mechanical manipulations of the tube during placement, and GI prokinetic drugs.151617181920 Small-bowel feeding tubes have been successfully placed using fluoroscopy or endoscopy, but not without added radiation exposure and/or cost.2122 Whether small-bowel feeding is advantageous to critically ill children is unknown. No randomized trials of gastric vs small-bowel feeds have been conducted in critically ill children. The aim of this study was to evaluate the effect of feeding tube position on nutrient delivery and feeding complications, including microaspiration, in critically ill children receiving mechanical ventilation.
| Materials and Methods |
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Study Protocol
Randomization:
Patients were randomized to receive either gastric or small-bowel feedings. Randomization was performed in blocks of 12 with a ratio of five gastric to seven small-bowel patient assignments. This randomization scheme was based on a 70% success rate for bedside placement of small-bowel feeding tubes,19 and designed to allow equal numbers of successfully placed tubes in both treatment groups. If a patient was randomized to the small-bowel group and the tube could not be successfully placed following randomization, the patient exited the study. If a feeding tube became dislocated later during the course of the study, attempts were made to replace the tube in the location to which the patient was originally randomized. If a small-bowel tube could not be replaced after dislocation, a gastric tube was placed and tube feedings and data collection were continued. Randomization was stratified for the presence of gastroesophageal reflux. Patients were categorized as having gastroesophageal reflux if they had a prior diagnostic study demonstrating reflux and/or were being treated for reflux. A pharmacist not otherwise involved in patient care determined the randomization sequence using a computer-generated table.
Tube Placement: Flexible 6F or 8F feeding tubes with stylets (Kangaroo Enteral Feeding Products; Sherwood Medical; St. Louis, MO) were placed in all patients by one of two investigators using a previously described standard technique.1819 During both gastric and small-bowel feeding tube placement, the tube was intermittently aspirated and the secretions tested for color, pH, and bilirubin concentration.23 These visual and biochemical indictors were used to guide tube placement. The final location of the feeding tube port within the GI tract was confirmed by abdominal radiography.
Feeding Regimen: Following tube placement, continuous feedings were initiated with an age-appropriate enteral formula. Infants received the formula that they were fed prior to hospitalization; children 1 to 10 years old received PediaSure (Ross Products Division; Abbott Laboratories; Columbus, OH), and children and adolescents > 10 years old received Jevity (Ross Products Division). Feedings were initiated at a rate of 2 to 5 mL/h and were advanced by 2 to 10 mL/h until the feeding rate goal was achieved. Feeding tubes were aspirated approximately every 4 h while feeds were being advanced in order to measure residual volumes. If the residual volume was greater than the volume administered during the previous 2 h, feeds were generally held for 1 to 2 h. Feeds were advanced at the discretion of the bedside nurse based on the childs age and observed feeding tolerance. The feeding rate goal was calculated to provide a daily caloric goal based on age, body weight, and recommended daily allowances.24 All patients were fed with the head elevated 30 to 45°.
Outcome Measures: The primary outcome measure was the percentage of daily caloric goal achieved during tube feeding. Secondary outcome measures were the incidence of aspiration and other feeding complications such as vomiting, diarrhea, and abdominal distension. Aspiration was assessed by the detection of gastric pepsin in tracheal secretions.2526 Tracheal secretions (0.1 to 0.5 mL) were collected from the endotracheal tube daily between 8 AM and 11 AM. Tracheal secretions were collected without the use of saline solution lavage. Diarrhea was defined as the presence of liquid stool at least three times per day. Abdominal distension was determined by serial physical examinations. Patients were evaluated daily for the duration of tube feeding or for 14 days if the duration of tube feeding was > 14 days.
Other Data Collected: Other data collected included age; sex; diagnosis; pediatric risk of mortality (PRISM) score27 on the day of PICU admission; number of days fasted prior to the initiation of tube feeds; presence of a cuffed endotracheal tube; daily weight; daily net fluid balance; daily chest radiographic findings; serum prealbumin concentration on days 1, 4, 7, 10, and 13 of tube feedings; number of days in which feedings were interrupted for > 1 h; number of feeding tube replacements; duration of tube feeding, mechanical ventilation, intensive care and hospitalization; and mortality. Daily net fluid balance was defined as the total fluid input minus output each day, and did not take into account insensible fluid losses. Tube feedings were interrupted when deemed necessary by the physicians and nurses providing the clinical care. Daily chest radiographs were obtained on all patients for the duration of mechanical ventilation and for several days after extubation. Due to the relatively small size of pediatric patients, the upper abdomen could be sufficiently visualized on most chest radiographs to determine the location of the feeding tube port.
Laboratory Methods: Serum prealbumin concentration was measured using rate nephelometry. Tracheal secretion pepsin was detected by a previously described Western blot immunoassay using a rooster polyclonal antibody against human pepsin.2526 The lower detection limit of the immunoassay is 1 µg/mL. Both prealbumin and pepsin analysis were performed by laboratory personnel blinded to group assignment.
Statistical Analysis: Previous randomized studies1013 in adults have shown a 15 to 22% difference in the percentage of daily caloric goal achieved between gastric and small-bowelfed patients. Based on estimates from these studies, a type I error rate of 5%, a type II error rate of 20% (power 80%), and a two-tailed alternative hypothesis, approximately 30 patients were needed in each group to detect a 15% difference in the percentage of daily caloric goal achieved. Based on a 70% success rate for placement of small-bowel tubes, 42 patients were randomized to the small-bowel group.19
Categorical data were expressed as the absolute count and percentage in each category. Categorical data were compared between the gastric and small-bowel feeding tube groups using Fisher exact tests. Ordinal data (PRISM scores) were expressed as median and range, and compared between groups using Mann-Whitney U tests. Continuous data were expressed as mean and SD, and compared between groups using independent t tests. Baseline body weight (first study day) was expressed as a percentage of ideal body weight based on length and sex.28 Change in body weight per day over the course of tube feedings was expressed as a percentage of body weight on the first study day. Caloric intake achieved per day was expressed as a percentage of the daily caloric goal. Daily net fluid balance was expressed per body surface area. Groups were compared using an intention-to-treat analysis. If a small-bowel tube became displaced during the course of the study and could not be replaced, the patient remained in the small-bowel group for the purpose of data analysis. An efficacy analysis was also performed, using only data collected on days during which the feeding tube was in the position to which the patient had been randomized, on select variables including the percentage of caloric goal achieved and the proportion of tracheal aspirates positive for pepsin.
| Results |
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Using an intention-to-treat analysis, the gastric group achieved a lower percentage of their daily caloric goal compared to the small-bowel group (Table 2 ). The groups were similar in the number of tube feeding days, percentage change in body weight per day, change in prealbumin concentration per day, and net fluid balance per day. The number of patients with vomiting, diarrhea, abdominal distension, and feeding interruptions were similar between the two groups (Table 2). Tube feedings were temporarily interrupted for at least 1 h on 121 days in the gastric group and 121 days in the small-bowel group (Table 3 ). Tracheal extubation was the most common reason for interrupting tube feedings in both groups. The total number of mechanical ventilator, intensive care, and hospital days tended to be longer in the small-bowel group, although the differences were not significant (Table 2). Five patients died, one patient in the gastric group and four patients in the small-bowel group (p = 0.2).
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Using an efficacy analysis, similar findings were obtained for the percentage of daily caloric goal achieved and pepsin positivity. The gastric group achieved a lower percentage of their daily caloric goal compared to the small-bowel group (30 ± 23% vs 47 ± 23%, p = 0.01). No differences were found between the gastric and small-bowel groups in the proportion of tracheal aspirates positive for pepsin (50 of 146 aspirates vs 39 of 148 aspirates, p = 0.2). Within the small-bowel group, no differences were found in the number of tracheal aspirates positive for pepsin between patients with tubes proximal to the third duodenal segment and those with more distal tubes (6 of 33 aspirates vs 33 of 115 aspirates, p = 0.3).
| Discussion |
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The nutritional support achieved by critically ill patients is determined by feeding tolerance and the ability to advance the rate of feeding delivery until the goal is achieved. Our results show that feedings were interrupted frequently and at a similar rate in both gastric- and small-bowelfed patients. Similar to research in adults, our patients feedings were most commonly interrupted for procedures and diagnostic tests.29 Whether feeds need to be interrupted during certain procedures and tests, especially when delivered transpylorically, is controversial. A randomized trial30 conducted in children receiving mechanical ventilation showed that continuation of transpyloric feeds during the weaning and extubation process resulted in a greater percentage of caloric goal achieved with no increase in adverse events, including aspiration. Due to the unblinded nature of our study, the duration for which tube feeds were held once interrupted may have been longer in the gastric group than the small-bowel group. In addition, tube feedings tended to be administered for a greater number of days in the small-bowel group, although the difference was not statistically significant. Since feeding rates are advanced over time, the trend for a longer duration of tube feeding in the small-bowel group could potentially account for the greater average percentage caloric goal achieved over the course of the study.
It is not known whether the difference found between the gastric and small-bowel groups in the percentage of the caloric goal achieved is clinically important. The relatively low average percentage caloric goal achieved in both groups in part reflects the fact that patients were in the period of feeding advancement once the study was initiated. Prealbumin concentration increased in both groups concurrent with a decrease in body weight over the duration of tube feedings. The pattern of increasing prealbumin concentration and decreasing weight may represent fluid remobilization, as our patients were typically not fed until after the initial resuscitation phase of their illness. Although daily net fluid balance was positive, this measurement did not take into account insensible water losses.
We found no difference in the rate of microaspiration between children receiving mechanical ventilation fed via gastric and small-bowel tubes. The presence of pepsin in tracheal secretions has been used as a marker of aspiration in both animal and human studies.252631 Pepsinogens produced by chief cells within the fundus of the stomach are hydrolyzed to active pepsins by the acidity of the stomach. Pepsin enters tracheal secretions when gastric contents reflux into the upper esophagus and are aspirated into the airway. Pepsin is believed to be a specific marker of microaspiration but may lack sensitivity.26 The duration of time that pepsin can be detected immunologically in tracheal secretions after an aspiration episode is unknown. In our study, tracheal secretions were sampled only once per day, and the overall incidence of aspiration was 63%. Infrequent sampling may lead to false-negative results, and therefore underestimate the incidence of aspiration. However, the pepsin test was applied uniformly to both feeding tube groups, and no difference in the frequency of aspiration events between groups was observed. No "gold standard" exists for the bedside detection of aspiration in children receiving mechanical ventilation. Studies67101112 in critically ill adults have used radiographic criteria to detect episodes of pulmonary aspiration. As evidenced by our patients admitting diagnoses, most children hospitalized in the PICU have respiratory disease as their initial problem. The high frequency of infiltrates on baseline chest radiographs makes detection of aspiration by chest radiographic findings a difficult process. Also, chest radiographs cannot differentiate aspiration of gastric contents from aspiration of oral pharyngeal secretions.
Several factors may contribute to gastroesophageal reflux and aspiration even when feeds are delivered transpylorically. The lower esophageal sphincter is the primary physiologic barrier preventing gastroesophageal reflux. The presence of a feeding tube passing through the pharynx can lead to increased frequency of transient relaxations of the lower esophageal sphincter.32 A tube crossing the lower esophageal sphincter may also interfere with sphincter function, predisposing the patient to gastroesophageal reflux. Some authors33 have suggested that feeding tube ports must be located in the third duodenal segment or beyond to prevent reflux and aspiration. However, the distal delivery of nutrients may itself increase the production of gastric secretions. In one study of critically ill trauma patients, gastric output nearly doubled after the institution of jejunal feedings.34 Most of our small-bowelfed patients had feeding tube ports located at the third duodenal segment or beyond. No relationship was found between the location of the feeding tube port within the small bowel and the occurrence of microaspiration.
Limitations of our study include the early exit of 12 patients randomized to the small-bowel group because small-bowel tubes could not be placed at the bedside. Elimination of patients after randomization has the potential to lead to systematic bias compromising the validity of the results. Other studies in adults used fluoroscopy or endoscopy to place small-bowel tubes when bedside placement was unsuccessful. Our study participants were infants and children. The degree of radiation exposure and/or invasiveness of these techniques were not justified for study purposes alone in this vulnerable population. Therefore, we designed a randomization scheme and exit criteria that would result in near equal numbers of patients in each group. Our study was not blinded, and knowledge of tube position within the GI tract might have influenced clinicians decisions on feeding management. However, the study could not reasonably be blinded since feeding tube position is usually easy to observe on pediatric chest radiographs. Laboratory personnel blind to group assignment assessed tracheal aspirate pepsin and serum prealbumin concentration. Infrequent sampling of tracheal secretions may have underestimated the overall incidence of aspiration or interfered with differentiation of aspiration risk between groups.
| Conclusion |
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| Footnotes |
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This work was performed at the Childrens Hospital of Michigan and supported by a grant from the Blue Cross Blue Shield Foundation of Michigan.
These findings have been presented in part at the College of Chest Physicians Annual Meeting, San Diego, CA, November 27, 2002.
Received for publication October 15, 2003. Accepted for publication March 8, 2004.
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