Respiratory Research in the Critically Ill Pediatric Patient: Why Is It So Difficult?

Curley, Martha A. Q.

doi:10.4187/respcare.01255

Cited by 9 publications

(5 citation statements)

References 43 publications

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“…Zimmerman et al insist that excellent paediatric care is coupled with the inclusion of research. However, undertaking research in specialised populations is challenging . Parents and health‐care professionals are sometimes protective of children and reluctant to involve them in research, although this was not seen in our study.…”

Section: Discussionmentioning

confidence: 66%

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Flushing of peripheral intravenous catheters: A pilot, factorial, randomised controlled trial of high versus low frequency and volume in paediatrics

Kleidon

Keogh

Flynn

et al. 2019

J Paediatrics Child Health

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Aim: To test the feasibility of an efficacy trial comparing different flushing frequencies and volumes to reduce peripheral intravenous cannula (PIVC) failure in paediatric inpatients. Methods: Pilot, 2 × 2 factorial, randomised controlled trial comparing PIVC flushing techniques in intervention pairs: (i) low volume (3 mL) versus high volume (10 mL); and (ii) low frequency (24 hourly) versus high frequency (6 hourly). Patients were excluded if: fluids were restricted, weight < 5 kg, PIVC already in situ for >24 h or continuous infusion. The primary end-point was feasibility (eligibility, recruitment, retention, protocol adherence, missing data and sample size estimates) of a large trial. Secondary end-points were PIVC failure (composite and individual), bloodstream infection and mortality. Results: A total of 919 children were screened from April to November 2015, with 55 enrolled. Screening feasibility criteria were not met, mainly due to continuous infusions and PIVCs in situ >24 h or planned for imminent removal. However, 80% of eligible participants consented, 2% withdrew, protocol adherence was 100%, and there was no missing primary end-point data. PIVC failure was significantly higher (hazard ratio = 2.90, 95% confidence interval: 1.11-7.54) in the 3 mL compared to the 10 mL group. There was no difference in failure between frequency groups (hazard ratio = 0.91, 95% confidence interval: 0.36-2.33). There was no interaction effect (P = 0.22). Conclusion: Trial feasibility proved challenging due to eligibility criteria, which could be improved with additional recruiting staff. Firm conclusions cannot be made based on this small sample, but flush volume may impact PIVC failure.

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Section: Discussionmentioning

confidence: 66%

“…The feasibility of this protocol in the paediatric population has not been tested. Research in paediatric patients is challenging due to their distinctive physiology and psychology . Children's vascular access needs and hydration requirements are unique, and research protocols have to reflect this.…”

mentioning

confidence: 99%

Flushing of peripheral intravenous catheters: A pilot, factorial, randomised controlled trial of high versus low frequency and volume in paediatrics

Kleidon

Keogh

Flynn

et al. 2019

J Paediatrics Child Health

View full text Add to dashboard Cite

show abstract

“…These findings are unsurprising given many respiratory interventions lack efficacy data to support their application. 64,65 Whilst we used the RAND/UCLA to help overcome this challenge, it is clear rigorous data are needed to support clinical decision-making regarding ETS in the PICU. Revisions of the PAWS guideline will be required in future to incorporate new evidence (studies assessing the application of an intervention or the guideline in clinical practice), with iterations hopefully adding clarity to areas of current uncertainty.…”

Section: Discussionmentioning

confidence: 99%

The Paediatric AirWay Suction (PAWS) appropriateness guide for endotracheal suction interventions

Schultz

Charles

Long

et al. 2022

Australian Critical Care

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Background/objective: Endotracheal suction is an invasive and potentially harmful technique used for airway clearance in mechanically ventilated children. Choice of suction intervention remains a complex and variable process. We sought to develop appropriate use criteria for endotracheal suction interventions used in paediatric populations. Methods: The RAND Corporation and University of California, Los Angeles Appropriateness Method was used to develop the Paediatric AirWay Suction appropriateness guide. This included defining key terms, synthesising current evidence, engaging an expert multidisciplinary panel, case scenario development, and two rounds of appropriateness ratings (weighing harm with benefit). Indications (clinical scenarios) were developed from common applications or anticipated use, current practice guidelines, clinical trial results, and expert consultation. Results: Overall, 148 (19%) scenarios were rated as appropriate (benefit outweighs harm), 542 (67%) as uncertain, and 94 (11%) as inappropriate (harm outweighs benefit). Disagreement occurred in 24 (3%) clinical scenarios, namely presuction and postsuction bagging across populations and age groups. In general, the use of closed suction was rated as appropriate, particularly in the subspecialty population 'patients with highly infectious respiratory disease'. Routine application of 0.9% saline for nonrespiratory indications was more likely to be inappropriate/uncertain than appropriate. Panellists preferred clinically indicated suction versus routine suction in most circumstances. Conclusion: Appropriate use criteria for endotracheal suction in the paediatric intensive care have the potential to impact clinical decision-making, reduce practice variability, and improve patient outcomes.

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“…Co-enrollment guidelines exist for adult resuscitation studies [4], pediatric [20] and adult [10] critical care. Public health mandates to answer research questions quickly during pandemics have encouraged co-enrollment of patients in treatment and observational studies [21].…”

Section: Discussionmentioning

confidence: 99%

Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences

et al. 2013

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IntroductionResearch on co-enrollment practices and their impact are limited in the ICU setting. The objectives of this study were: 1) to describe patterns and predictors of co-enrollment of patients in a thromboprophylaxis trial, and 2) to examine the consequences of co-enrollment on clinical and trial outcomes.MethodsIn an observational analysis of an international thromboprophylaxis trial in 67 ICUs, we examined the co-enrollment of critically ill medical-surgical patients into more than one study, and examined the clinical and trial outcomes among co-enrolled and non-co-enrolled patients.ResultsAmong 3,746 patients enrolled in PROTECT (Prophylaxis for ThromboEmbolism in Critical Care Trial), 713 (19.0%) were co-enrolled in at least one other study (53.6% in a randomized trial, 37.0% in an observational study and 9.4% in both). Six factors independently associated with co-enrollment (all P < 0.001) were illness severity (odds ratio (OR) 1.35, 95% confidence interval (CI) 1.19 to 1.53 for each 10-point Acute Physiology and Chronic Health Evaluation (APACHE) II score increase), substitute decision-makers providing consent, rather than patients (OR 3.31, 2.03 to 5.41), experience of persons inviting consent (OR 2.67, 1.74 to 4.11 for persons with > 10 years' experience compared to persons with none), center size (all ORs > 10 for ICUs with > 15 beds), affiliation with trials groups (OR 5.59, 3.49 to 8.95), and main trial rather than pilot phase (all ORs > 8 for recruitment year beyond the pilot). Co-enrollment did not influence clinical or trial outcomes or risk of adverse events.ConclusionsCo-enrollment was strongly associated with features of the patients, research personnel, setting and study. Co-enrollment had no impact on trial results, and appeared safe, acceptable and feasible. Transparent reporting, scholarly discourse, ethical analysis and further research are needed on the complex topic of co-enrollment during critical illness.

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Respiratory Research in the Critically Ill Pediatric Patient: Why Is It So Difficult?

Cited by 9 publications

References 43 publications

Flushing of peripheral intravenous catheters: A pilot, factorial, randomised controlled trial of high versus low frequency and volume in paediatrics

Flushing of peripheral intravenous catheters: A pilot, factorial, randomised controlled trial of high versus low frequency and volume in paediatrics

The Paediatric AirWay Suction (PAWS) appropriateness guide for endotracheal suction interventions

Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences

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