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. 2015 May 22;2015(5):CD008096. doi: 10.1002/14651858.CD008096.pub4

Elbadawy 2014.

Methods Single‐centre parallel randomised controlled 3‐arm trial
Setting: Department of Critical Care Medicine, Egypt
Sample size; minimum sample size required was 20 patients for each group to achieve a power of 80 % and alpha of 0.05.
Participants 60 participants, with closed traumatic severe brain injury in need for prolonged MV who continued to have a Glasgow coma score (GCS) of less than 8 after initial stabiliSation of their haemodynamic and oxygenation.
Mean age not available.
Gender (male/female ratio):
NGT + intubation: 8/12
PEG + intubation: 9/11
PEG + tracheostomy: 11/9
Exclusion criteria:
History of known respiratory disease, thoracic trauma, multiple traumatic injuries including abdominal or spinal trauma, massive or untreatable loculated ascites, previous abdominal surgery, uncorrected coagulopathy.
Interventions NGT + intubation (n = 20): nasogastric tube and endotracheal tube was inserted through which MV was applied.
PEG + intubation (n = 20): PEG was done within 24 hours of endotracheal intubation using percutaneous pull gastrostomy kit using Bard Ponsky pull through technique
PEG + tracheostomy (n = 20): percutaneous dilatational tracheostomy (PDT) and PEG were done within 24 hours of endotracheal intubation.
In all study groups, bolus enteral nutrition was given which was initiated within 24 hours after intubation for patients in group (A) and 24 hours after performance of gastrostomy for group (B and C). All the patients were nursed in a semi recumbent position (30‐45o). Proton pump inhibitor was given intravenously for stress ulcer prophylaxis (pantoprazole 40mg once daily) for each patient in all the study groups
Outcomes Primary

  1. Intervention failures as defined by any event leading to failure to introduce the tube, recurrent displacement and treatment interruption (feeding interruption, blocking or leakage of the tube, no adherence to treatment).


Secondary

  1. Adverse events including ventilation assisted pneumonia

  2. Duration of ICU stay.

  3. Duration of mechanical ventilation

  4. Duration of hospital stay.

  5. Mortality rate of the patients

  6. Vital signs


Adverse events including: infection of tracheostomy wound, bleeding from tracheostomy, pneumothorax, tracheo‐oesophageal fistula, infection of gastrostomy wound, GIT Fistula, GIT Perforation, buried pumper syndrome (PEG tube erodes and migrates through the gastric wall), paranasal sinusitis.
Notes No statistically or clinically significant differences between comparison groups at baseline for gender, mechanism of injury, characteristics based on computer tomography, APACHE II score, Glasgow coma score, or other vital sign sand biochemical parameters.
We combined data for the PEG + intubation and PEG + tracheostomy groups into a single PEG group for comparison with NGT.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Described as randomised, consecutive computer randomisation (further information from study investigator)
Allocation concealment (selection bias) High risk Not concealed (further information from study investigator)
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not possible for this type of intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not explicitly stated by the study investigators
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No attrition reported
Selective reporting (reporting bias) Low risk Relevant outcomes were analysed, protocol not available for assessment
Other bias Low risk None