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530  P R I N C I P L E S   A N D   P R A C T I C E   O F   C R I T I C A L   C A R E



            Research vignette
            Juve-Udina M-E, Valls-Miro C, Carreno-Granero A, Maria-Estalella G,   to  critical  care  nursing  there  are  omissions  and  discrepancies  in
            Monterde-Prat D et al. To return or to discard? Randomised trial on   both the conduct of the study and the analysis that undermine the
            gastric residual volume management. Intensive Critical Care Nursing   credibility of the findings.
            2009; 25 (5): 258–67.
                                                              The  value  for  maintaining  GRV  within  safe  limits,  i.e.  below
            Abstract                                          5 mL/kg was cited by Horn and colleagues  in their secondary
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            Objectives                                        analysis of intermittent versus continuous feeding in a paediatric
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            The study aimed to determine the effect of returning or discarding   ICU.  Horn  and  colleagues   used  the  value  recommended  by
            the gastric residual volume (GRV) on gastric emptying delays and   Taylor and Baker  (the primary reference) in their paper published
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            feeding, electrolyte balance and patient outcomes among critically   on paediatric enteral nutrition. There was no information on how
            ill patients. Gastric emptying delay (GED) was defined as the dif-  this value was derived and it may not be appropriate for adults.
            ficulty  in  maintaining  GRV  within  safe  limits,  i.e.  below  5 ml/kg.   The GED was categorised into three groups but the rationale for
            The GED was categorised as light GED (151–250 mL/6 hours), mod-  using  these  categories  was  not  provided.  Other  important  out-
            erate  GED  (251–350 mL/6  hours)  or  severe  GED  (>350 mL/  comes of interest are not well defined. For example testing glucose
            6 hours). 353                                     values  in  pulmonary  secretions  is  not  an  acceptable  method  to
                                                              define pulmonary aspiration. The report does not explicitly define
            Methods                                           the ‘discard’ group.
            The prospective, randomised clinical trial was conducted in a single
            medical-surgical intensive care unit (ICU) of a public university hos-  In conducting the study, randomisation procedures are explained
            pital. Patients admitted to the ICU for longer than 48 hours, aged   but it is unclear who controlled allocation of patients to the return
            18  or  older,  who  had  haemodynamic  monitoring  and  were  fed   or discard group, thereby opening the study to selection bias if the
            enterally or parenterally were recruited to the study over one year.   allocation was inconsistent. The study is unblinded as expected but
            Participants were excluded if connected to an intermittent gastric   mention of why it was not possible to blind should be included in
            aspiration system. Computer-generated randomisation was used   the report. All patients were accounted for but ‘intention to treat’
            to randomise participants to the return (intervention) or discard   principles were not used. The type of ICU, but not its location, is
            (control) group. The estimated sample size (59 participants in each   reported  as  mixed  medical-surgical  (general)  ICU  which  are  the
            group)  was  informed  by  sample  size  calculations.  The  study    most common ICUs in Australia. The selection criteria were listed
            finished for a participant if: (1) there was no need for further GRV   and  recruitment  was  described  as  continuous  over  a  year.  It  is
            monitoring, (2) occurrence of adverse event associated with the   revealed  later  in  the  paper  that  recruitment  did  not  occur  for  2
            procedure  (pulmonary  aspiration  or  cardio-respiratory  arrest   months over summer although no reason for not recruiting during
            during or immediately after the procedure), (3) faecal aspirates, (4)   this period was provided. This may have been an important omis-
            major protocol error or (5) death. Gastric residual volumes were   sion as acknowledged by the authors.
            checked every 6 hours and an algorithm was used to guide man-  An  algorithm  was  used  to  guide  management  of  GRV  but  it  is
            agement of GRV. Data were collected by the investigators or by the   unclear  and  two  standard  volumes  were  prescribed  for  enteral
            trained registered nurses from the ICU and included the incidence   feeds. While feeding was administered continuously the algorithm
            of (1) blocked NGT; (2) pulmonary aspiration episodes; (3) intoler-  indicates different administration and cessation times which are
            ance episodes (nausea, vomiting, diarrhoea and abdominal disten-  quite confusing.
            sion);  (4)  enteral  feeding  delays;  (5)  hyperkalaemia  episodes;  (6)
            hyperglycaemia episodes and (7) discomfort episodes, identified   The data collected on factors that may be potentially affected by
            by significant changes in vital signs and also from the Ramsay seda-  the return or discard of GRV were impressive. The lack of signifi-
            tion score. 354                                   cance between groups is disappointing but not unexpected. Even
                                                              though sample size calculations were performed, the estimates for
            Results and Conclusion
            No significant differences were found in participant demographics   the effect size may not be realistic and subgroup analysis was not
            or outcome measures between the groups. The exceptions were   decided a priori.
            participants in the intervention group had a lower incidence and   While the limitations of the study were discussed, important issues
            severity of delayed gastric emptying episodes (P = 0.001) and more   such as conduct of the study in a single centre, use of subgroup
            episodes  of  hyperglycaemia.  The  investigators  concluded  that   analyses and not using intention to treat analysis were omitted. A
            returning  gastric  aspirates  improved  GRV  management  without   major  limitation  in  our  opinion  was  to  include  patients  who
            increasing the risk for potential complications.  received  parenteral  nutrition.  It  would  be  more  informative  to
                                                              study only those patients receiving enteral feeding in a sufficiently
            Critique                                          large sample using a strict standardised feeding regimen to assess
            Gastric residual volume (GRV) is routinely measured in many ICUs   the effect of administering enteral nutrition and the effect of GED.
            to  monitor  gastric  tolerance  to  enteral  feeding  and  abdominal   Patients who receive parenteral nutrition are likely to have impaired
            decompression  and  drainage  for  patients  not  fed  enterally. This   gut function and their inclusion only confuses the results. Perform-
            study compared two methods of managing gastric aspirate after it   ing some statistical modelling may have enhanced understanding
            was removed from the stomach, i.e. return or discard. Gastric aspi-  of the outcomes of the study.
            rates were returned in the ‘intervention’ group if the GRV was not
            greater than 250 mL, if so then the return volume was limited to   There is a wide variation in the management of GRV and little avail-
            250 mL. Whilst using a robust study design in an area of relevance   able evidence to guide practice.  The volume of GRV considered
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