Jejunal Tube Self Guided

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Intensive Care Med DOI 10.1007/s00134-009-1535-z

BRIEF REPORT

Ulrike Holzinger Reinhard Kitzberger Andja Bojic Marlene Wewalka Wolfgang Miehsler Thomas Staudinger Christian Madl

Comparison of a new unguided self-advancing jejunal tube with the endoscopic guided technique: a prospective, randomized study

Received: 25 February 2009 Accepted: 22 May 2009 Ó Springer-Verlag 2009

U. Holzinger ()) Á R. Kitzberger Á M. Wewalka Á W. Miehsler Á C. Madl Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Intensive Care Unit 13H1, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria e-mail: [email protected] Tel.: ?43-1-404004767 Fax: ?43-1-404004797 A. Bojic Á T. Staudinger Department of Internal Medicine I, Intensive Care Unit 13i2, Medical University of Vienna, Vienna, Austria

Abstract Objective: To compare the success rate of correct jejunal placement of a new self-advancing jejunal tube with the gold standard, the endoscopic guided technique, in a comparative intensive care unit (ICU) patient population. Design: Prospective, randomized study. Setting: Two medical ICUs at a university hospital. Patients: Fortytwo mechanically ventilated patients with persisting intolerance of intragastric enteral nutrition despite prokinetic therapy. Methods: Patients were randomly assigned to receive an unguided selfadvancing jejunal feeding tube (Tiger TubeTM) or an endoscopic guided jejunal tube (FrekaÒ Trelumina). Primary outcome measure was the success rate of correct jejunal placement after 24 h. Results: Correct jejunal tube placement was reached in all 21 patients using the endoscopic guided technique whereas the unguided self-advancing jejunal tube could be placed successfully in 14 out of 21 patients (100% versus 67%; P = 0.0086). In the remaining seven

patients, successful endoscopic jejunal tube placement was performed subsequently. Duration of tube placement was longer in the unguided self-advancing tube group (20 ± 12 min versus 597 ± 260 min; P \ 0.0001). Secondary outcome parameters (complication rate, number of attempts, days in correct position with accurate functional capability, days with high gastric residual volume, length of ICU stay, ICU mortality) were not statistically different between the two groups. No potentially relevant parameter predicting the failure of correct jejunal placement of the self-advancing tube could be identified. Conclusions: Success rate of correct jejunal placement of the new unguided self-advancing tube was significantly lower than the success rate of the endoscopic guided technique. Keywords Jejunal feeding tube Á Critical illness Á Enteral nutrition

Introduction
In critically ill patients, enteral feeding (EN) via a nasogastric tube is often associated with gastrointestinal complications leading to interruption of the EN [1]. In these patients, international guidelines recommend

intestinal feeding via a jejunal feeding tube to facilitate adequate nutritional supply [2–4]. The gold standard for the placement of a jejunal feeding tube is the endoscopic guided technique, with a success rate of over 90% [5, 6]. However, this technique requires experienced endoscopists and is therefore of

limited availability [5]. Various alternative techniques have been clinically investigated, most of them resulting in lower success rates than the endoscopic guided technique [7–12]. Recently, a new unguided self-advancing jejunal tube has been introduced in clinical practice [13]. We compared the success rate of correct jejunal placement of this new self-advancing jejunal tube with the gold standard, the endoscopic guided technique, in a prospective randomized trial in a comparative ICU patient population.

Patients and methods
Study design

endoscope (GIF-Q 180, Evis Exera II, Olympus, Tokyo, Japan). In the endoscopic guided group, a FrekaÒ Trelumina jejunal tube (Fresenius Kabi AG, Bad Homburg, Germany) was used. In the unguided self-advancing tube group the Tiger TubeTM (CookÒ Medical Inc., Bloomington, IN, USA) was used. This new jejunal feeding tube is a single lumen tube with small alternating cilia-like plastic flaps, which help to advance it into the small bowel via peristalsis. The placement was done according to the manufacturer’s instructions. Metoclopramide i.v. (10 mg) and 200 mg erythromycin i.v. were administered 15 min before the procedure and 1 h after correct gastric placement [16]. In patients with incorrect position, a second attempt was performed. Correct jejunal position was confirmed by daily routine X-ray. Functional capability and patency of jejunal feeding tubes was checked twice per day.

This prospective, randomized study was investigator initiated and investigator driven. The study protocol Statistical analysis conformed to the ethical guidelines of the Declaration of Helsinki and was approved by the research ethics com- The primary outcome measure was the success rate of mittee of the Medical University of Vienna. correct jejunal placement after 24 h. Secondary outcome measures were duration of jejunal tube placement, number of attempts until correct position, number of days in Patients and setting correct position and functional capability, days with high GRV ([250 ml/24 h) after correct placement, complicaThe study was performed in the medical Intensive Care tions of placement and adverse side-effects of jejunal Units (ICUs) of the Department of Medicine I and III at tubes during ICU stay, length of ICU stay, and ICU the Medical University Hospital of Vienna. mortality. Patients were eligible for inclusion if they were older Sample size was calculated using Graph Pad Statmate than 18 years of age, intubated, mechanically ventilated software (GraphPad Software Inc., CA, USA). Antici[48 h, and had persisting intolerance of intragastric EN. pated proportions (success rate of correct jejunal This was defined as high gastric residual volumes (GRV) placement) were compared with a one-sided Z-test (0.98 (C250 ml/24 h) and/or repeated vomiting despite for the endoscopic guided group and 0.65 for the unguiadministration of erythromycin (200 mg thrice a day) and ded self-advancing jejunal tube group). A sample size of metoclopramide (10 mg thrice a day) for at least 24 h [14, 20 was calculated for a statistical power of 80%. Alpha 15]. GRV was evaluated twice in 24 h by interruption of was 0.05 (two-tailed). Since we expected one dropout in EN (for at least half an hour). GRV was not aspirated every group, sample size was defined as 21 per group. actively. EN was prescribed according to a standardized Data are expressed as mean ± standard deviation (SD). nutritional protocol. Patients were not enrolled in the The Mann–Whitney U test was used to compare differstudy if any of the following criteria were present: con- ences between numeric parameters when appropriate. traindication for EN or upper gastrointestinal endoscopy, Categorical data were analyzed using Fisher’s exact test. previous upper gastrointestinal surgery, signs of active An exploratory analysis to identify possible factors gastric bleeding and severe nasopharyngeal injuries or influencing the success rate of the new unguided selfstenosis as well as known upper gastrointestinal varicosis. advancing tube was added. Statistical analysis was carried out using Graph Pad Prism 5 Software (Graph Pad Software Inc., CA, USA). Jejunal tube placement P-value \0.05 was regarded to indicate statistical significance. Eligible patients were randomly assigned, in a 1:1 ratio, to receive an endoscopic guided or an unguided selfadvancing jejunal feeding tube. Endoscopic method of jejunal placement was per- Results formed according to the standard operating procedure of the ICU of the Department of Gastroenterology and Hepatol- Between February 2005 and February 2006, high GRV ogy. Procedures were performed with a fiber-optic (C250 ml/24 h) and/or repeated vomiting were observed

in 66 (40%) out of 163 ICU patients (ventilated [48 h). Twenty-four (36%) were responders to prokinetic therapy and tolerated continuation of intragastric EN. The remaining 42 (64%) patients were randomly assigned to receive an endoscopic guided or an unguided selfadvancing jejunal feeding tube. Baseline demographics, patient characteristics at ICU admission, and reason for ICU admission did not differ significantly between the two groups (Table 1). Correct jejunal tube placement was reached in all 21 patients using the endoscopic guided technique, whereas the unguided self-advancing jejunal tube could only be placed successfully in 14 out of 21 patients (100% versus 67%; P = 0.0086). In all seven patients in whom the self-advancing tube had failed to reach correct jejunal position after 24 h, successful endoscopic jejunal tube placement was performed subsequently. Duration of tube placement was longer in the unguided self-advancing tube group (Table 2). All other parameters (complication rate, number of attempts, days in correct position with accurate functional capability, days with high GRV, length of ICU stay, and ICU mortality) were not statistically different between the two groups. Severe side-effects of the jejunal tubes were neither observed during application nor during the
Table 1 Baseline characteristics of all patients Endoscopic guided group n = 21 Age (years) Male/female (no.) APACHE III score SAPS II score Gastric residual volume (ml) Admission reason, no. (%) Septic shock Cardiac arrest ALI/ARDS Liver failure Heart failure Others 57 ± 13 12/9 93 ± 28 63 ± 17 636 ± 298 5 5 3 3 1 4 (24) (24) (14) (14) (5) (19)

patients’ ICU stay. Complication observed during tube application was minor nose bleeding, with equal occurrence in both groups (three patients in each group). Potentially relevant demographic data concerning impaired gastric emptying for the 7 patients with unsuccessful tube placement compared with the 14 patients with successful tube placement are given in Table 3. There was no significant difference between these subsets of patients.

Discussion
This prospective, randomized study was performed to compare two methods of jejunal tube placement, an endoscopic guided and a new unguided self-advancing jejunal feeding tube, in a comparative ICU population. Success rate of correct jejunal placement of the new unguided self-advancing tube was significantly lower than the success rate of the endoscopic method. Despite aggressive efforts, early sufficient intragastric nutrition frequently fails because of impaired gastric emptying which leads to large GRV, vomiting, and

Unguided self-advancing group n = 21 57 ± 16 13/8 85 ± 22 54 ± 15 656 ± 318 6 3 5 1 2 4 (29) (14) (24) (5) (9) (19)

P-value 0.8306 1 0.3309 0.0869 0.8877 1 0.6965 0.6965 0.6060 1 1

Values are expressed as absolute numbers and percentage and as mean value ± standard deviation. P-value is given when appropriate APACHE acute physiology and chronic health evaluation, SAPS simplified acute physiology score Table 2 Comparison of outcomes between study groups Endoscopic guided group n = 21 Success rate, no (%) Duration of placement (min) Complication rate, no (%) Number of attempts Days in correct position Days with high gastric residual volume Length of ICU stay (days) ICU mortality, no (%) 21 (100) 20 ± 12 3 (14) 1.76 ± 1.0 8.2 ± 8 1.9 ± 2.1 17 ± 13 7 (33) Unguided self-advancing group n = 21 14 (67) 597 ± 260 3 (14) 1.52 ± 0.6 13.1 ± 9.6 2.6 ± 2.9 23 ± 17 6 (29) P-value 0.0086 \0.0001 1 0.7686 0.1168 0.5975 0.1212 1

Values are expressed as absolute numbers and percentage and as mean value ± standard deviation. P-value is given when appropriate

Table 3 Comparison of demographic data between patients with successful and unsuccessful jejunal placement using the unguided selfadvancing technique Unguided self-advancing group: failure (n = 7) Age (years) SAPS II score Gastric residual volume (ml) Norepinephrine therapy (lg/kg per min) Analgetic therapy (fentanyl mg/h) Sedative therapy (midazolam mg/h) Patients with history of diabetes mellitus, no (%) ICU mortality, no (%) 59 ± 20 59 ± 13 608 ± 246 0.16 ± 0.2 0.2 ± 0.17 9.5 ± 7.14 1 (14) 2 (29) Unguided self-advancing group: success (n = 14) 56 ± 15 52 ± 16 676 ± 351 0.12 ± 0.23 0.19 ± 0.15 10.5 ± 12.6 3 (21) 4 (29) P-value 0.5017 0.2168 0.8362 0.3389 0.9350 1.0000 1 1

Values are expressed as absolute numbers and percentage and as mean value ± standard deviation. P-value is given when appropriate

consequently reduced caloric supply [1, 17, 18]. Placement of feeding tubes beyond the pylorus can avoid this problem. In the present study, we tested a new unguided self-advancing jejunal tube. So far, only one small uncontrolled study using this feeding tube has been published and reported a high success rate ([80%) of correct jejunal placement [13]. In contrast, in our study the success rate of correct jejunal placement of this unguided self-advancing tube was markedly lower. The main reason for this difference may be the remarkably low severity of illness (median SAPS II score of 11) of the patients included in the previous uncontrolled study. In contrast the median SAPS II score of the patients included in our study was five times higher, reflecting more realistically most ICUs. The majority of patients who are intolerant to intragastric feeding have reduced, absent or reversed peristalsis. Consequently, prokinetic agents were used during application of the self-advancing tube [15, 16]. However, in our study even combination of metoclopramide and erythromycin could not completely restore peristalsis and led to a significantly lower rate of correct jejunal position in the unguided self-advancing group. In our patient population, with an obviously severely disturbed peristalsis, we could not identify any potentially relevant parameter predicting the failure of correct jejunal placement. Even the requirement of norepinephrine,

analgetic and sedative therapy was not significantly different between patients with successful and unsuccessful unguided self-advancing tube placement. Severe mucosal lesions which have been reported in a small case series for the unguided self-advancing tube were not observed [19]. Rate of minor nose bleeding was equal in both groups. Observing the exclusion criteria, application of both methods was safe in our study. The unguided self-advancing tube is easy to apply at the bedside and does not require specially trained staff. However, the observed low success rate of correct jejunal placement limits its clinical applicability. In particular in patients with persisting intolerance of intragastric EN despite prokinetic therapy who represent the target population for jejunal feeding a fast and reliable jejunal placement is essential.

Conclusion
The success rate of correct jejunal placement of the new unguided self-advancing tube was significantly lower than the success rate of the endoscopic guided technique. Therefore, the endoscopic guided technique remains the gold standard for the placement of jejunal feeding tubes.

References
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