Critical Appraisal Of A Randomised Controlled Trial - Nursing Assignment Help

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 Summary 

This study was well designed at the outset but unfortunately, the study did not follow the proposeddesign and only two interventions were compared to control. Hence the validity of the results isquestionable. Data was analysed for only 35% of enrolled patients and hence it is unclear if theintention to treat principle was followed. There was a significant amount of missing data. Manypatients were enrolled in the study despite having a diagnosis of pneumonia on day one.

INTERPRETATION OF RESULTS:

The primary outcome of this study was the incidence of VAP pneumonia as determined by the CPIS.The authors report that the main finding of the study was that patients who did not have an existingdiagnosis of pneumonia, who were randomised to receive chlorhexidine oral swabs twice daily, had a significantly lower incidence of VAP on day 3 of the study (24%), as compared to patients who did notreceive chlorhexidine ( 52%) (p=0.006). Comparatively, the incidence of VAP on day three, in patientswho received thrice daily toothbrushing and whom did not have a diagnosis of pneumonia on day one,was 40%. The difference in the incidence of VAP between patients who received toothbrushing andthose who did not was not statistically significant (p=0.54).Mean CPIS were also compared between chlorhexidine and control and toothbrushing and control onday 1 (n=192) and day 3 (n=87). The only significant difference in mean CPIS was between thechlorhexidine group (mean 4.36) and control (mean 5.36) on day 3 (p=0.02).The combined effect of toothbrushing and chlorhexidine was deemed to be non-significant so was not included in the final analysis model. No data was presented about the impact of combinedchlorhexidine and toothbrushing on incidence of VAP or CPIS (n=116 on day1). Similarly there wasno data presented for the primary outcome for the control group (n=123 on day 1).

Measurement and Quantification of Key VariablesVentilator-Associated Pneumonia.

Development ofVAP was quantified by using the CPIS.25 Microbialcultures of tracheal aspirates were performed by thehospital’s clinical support laboratory (which hasClinical Laboratory Improvement Amendmentscertification) by laboratory personnel who had noknowledge of any patient’s treatment assignment.Chest radiographs were interpreted by an intensivistboard certified in critical care medicine (C.S.) whohad no knowledge of any patient’s treatment assign-ment. Data for CPIS calculation were collected onstudy days 1, 3, 5, and 7.For the CPIS, points are assigned to 6 easilyobtained variables: temperature, white blood cellcount, tracheal secretions, oxygenation (calculatedas PaO2 divided by the fraction of inspired oxygen),findings on chest radiographs (no infiltrate, diffuseinfiltrate, localized infiltrate), and results of cultur-ing of tracheal aspirates (microscopic examinationand semiquantitative culture of tracheal secretions,scored by using the same scale as that used for theoral cultures). Points for each variable of the CPISare summed, yielding a total CPIS, which providesa range of scores from 0 to 12 for data analysis.

Effects of Intervention on VAP:

Table 2 presents results for the main effects oftoothbrushing and of chlorhexidine on the basis ofCPIS values at day 3. The interaction of toothbrush-ing and chlorhexidine was not significant, so theinteraction was not included in final analysis mod-els. Thus, the tables present results for main effectsof toothbrushing and chlorhexidine by treatment,rather than by treatment group assignment. Whenthe entire sample was considered,neither chlorhexidine nor tooth-brushing had significant effects onCPIS values or on pneumonia(CPIS ≥6). The interaction of tooth-brushing and chlorhexidine was not significant. 

Discussion:

VAP is associated with increased health carecosts, morbidity, and mortality. Chlorhexidine oralswabbing was effective in reducing early VAP inpatients in medical, surgical/trauma, and neuro-science ICUs who did not have pneumonia at base-line. Toothbrushing did not reduce the incidence of VAP, and combining toothbrushing and chlorhexi-dine did not provide additional benefit over use ofchlorhexidine alone.This project was a randomized, controlled clin-ical trial to determine if 2 oral care interventions,chlorhexidine and toothbrushing, would reduce therisk for VAP during the first week of intubation incritically ill adults receiving mechanical ventilation.
The sample was diverse in race and included bothmen and women. Severity of illness was appropriatefor a large urban medical center, and the VAP rateobserved was similar to published rates.

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