Dataset Information

Cross-sectional analysis on publication status and age representation of clinical studies addressing mechanical ventilation and ventilator-induced lung injury in infants and children.

ABSTRACT:

Objectives

We determined the number and time-to-public availability of study results of published and unpublished clinical studies in paediatric mechanical ventilation (MV) and ventilator-induced lung injury (VILI), which were registered as completed on ClinicalTrials.gov. Furthermore, we explored the pattern of represented research study subtopics and the corresponding study populations.

Setting

Literature search based on ClinicalTrials.gov, PubMed and Google Scholar from 9 July 2017 to 27 September 2017.

Primary and secondary outcome measures

Assessment, if studies included in our analysis had been published. Assessment of primary research focus, patient enrolment and age representation of the analysed studies.

Results

We identified n=109 registered and completed clinical studies on paediatric MV and VILI (enrolment: 22?233 participants). 71% were published, including data from 18?647 subjects. 29% of studies were unpublished, containing data from 3586 subjects. Median time-to-public availability of study results was 22 (IQR, 12.8-41.5) months. The most important study subtopics were biophysical and technical aspects of MV (32 studies), administration of drugs to mitigate VILI through various mechanisms (40 studies) and diagnostic procedures (16 studies). n=66/109 (61%) studies exclusively focused on children below 1?year of age and n=2/109 (2%) exclusively on children between 1 and 14 years.

Conclusions

One-third of clinical studies in paediatric MV and VILI registered as completed on ClinicalTrials.gov remained unpublished and contained data on 3586 study participants. The overall median time-to-public availability of study results was longer than the deadline of 12 months mandated by the Food and Drug Administration Amendment Act of 2007. Important and clinically relevant research study subtopics were represented in the research questions investigated in paediatric MV and VILI. The study population was skewed towards children younger than 1?year which indicates, that there is a substantial need for clinical VILI research in older children.

SUBMITTER: Patry C

PROVIDER: S-EPMC6252714 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Cross-sectional analysis on publication status and age representation of clinical studies addressing mechanical ventilation and ventilator-induced lung injury in infants and children.

Patry Christian C Kranig Simon S Rafat Neysan N Schaible Thomas T Toenshoff Burkhard B Hoffmann Georg F GF Ries Markus M

BMJ open 20181118 11

<h4>Objectives</h4>We determined the number and time-to-public availability of study results of published and unpublished clinical studies in paediatric mechanical ventilation (MV) and ventilator-induced lung injury (VILI), which were registered as completed on ClinicalTrials.gov. Furthermore, we explored the pattern of represented research study subtopics and the corresponding study populations.<h4>Setting</h4>Literature search based on ClinicalTrials.gov, PubMed and Google Scholar from 9 July ...[more]

PMID: 30455388

Similar Datasets

Project description:Introduction and aim:Studies regarding asynchrony in patients in the cardiac postoperative period are still only a few. The main objective of our study was to compare asynchronies incidence and its index (AI) in 3 different modes of ventilation (volume-controlled ventilation [VCV], pressure-controlled ventilation [PCV] and pressure-support ventilation [PSV]) after ICU admission for postoperative care. Methods:A prospective parallel randomised trialin the setting of a non-profitable hospital in Brazil. The participants were patients scheduled for cardiac surgery. Patients were randomly allocated to VCV or PCV modes of ventilation and later both groups were transitioned to PSV mode. Results:All data were recorded for 5 minutes in each of the three different phases: T1) in assisted breath, T2) initial spontaneous breath and T3) final spontaneous breath, a marking point prior to extubation. Asynchronies were detected and counted by visual inspection method by two independent investigators. Reliability, inter-rater agreement of asynchronies, asynchronies incidence, total and specific asynchrony indexes (AIt and AIspecific) and odds of AI ?10% weighted by total asynchrony were analysed. A total of 17 patients randomly allocated to the VCV (n=9) or PCV (n=8) group completed the study. High inter-rated agreement for AIt (ICC 0.978; IC95%, 0,963-0.987) and good reliability (r=0.945; p<0.001) were found. Eighty-two % of patients presented asynchronies, although only 7% of their total breathing cycles were asynchronous. Early cycling and double triggering had the highest rates of asynchrony with no difference between groups. The highest odds of AI ?10% were observed in VCV regardless the phase: OR 2.79 (1.36-5.73) in T1 vs T2, p=0.005; OR 2.61 (1.27-5.37) in T1 vs T3, p=0.009 and OR 4.99 (2.37-10.37) in T2 vs T3, p<0.001. Conclusions:There was a high incidence of breathing asynchrony in postoperative cardiac patients, especially when initially ventilated in VCV. VCV group had a higher chance of AI ?10% and this chance remained high in the following PSV phases.

Project description:BackgroundAnalysis of respiratory mechanics during mechanical ventilation (MV) is able to estimate resistive, elastic and inertial components of the working pressure of the respiratory system. Our aim was to discriminate the components of the working pressure of the respiratory system in infants on MV with severe bronchiolitis admitted to two PICU's.MethodsInfants younger than 1 year old with acute respiratory failure caused by severe bronchiolitis underwent neuromuscular blockade, tracheal intubation and volume controlled MV. Shortly after intubation studies of pulmonary mechanics were performed using inspiratory and expiratory breath hold. The maximum inspiratory and expiratory flow (QI and QE) as well as peak inspiratory (PIP), plateau (PPL) and total expiratory pressures (tPEEP) were measured. Inspiratory and expiratory resistances (RawI and RawE) and Time Constants (KTI and KTE) were calculated.ResultsWe included 16 patients, of median age 2.5 (1-5.8) months. Bronchiolitis due to respiratory syncytial virus was the main etiology (93.8%) and 31.3% had comorbidities. Measured respiratory pressures were PIP 29 (26-31), PPL 24 (20-26), tPEEP 9 [8-11] cmH2O. Elastic component of the working pressure was significantly higher than resistive and both higher than threshold (tPEEP - PEEP) (P < 0.01). QI was significantly lower than QE [5 (4.27-6.75) v/s 16.5 (12-23.8) L/min. RawI and RawE were 38.8 (32-53) and 40.5 (22-55) cmH2O/L/s; KTI and KTE [0.18 (0.12-0.30) v/s 0.18 (0.13-0.22) s], and KTI:KTE ratio was 1:1.04 (1:0.59-1.42).ConclusionsAnalysis of respiratory mechanics of infants with severe bronchiolitis receiving MV shows that the elastic component of the working pressure of the respiratory system is the most important. The elastic and resistive components in conjunction with flow profile are characteristic of restrictive diseases. A better understanding of lung mechanics in this group of patients may lead to change the traditional ventilatory approach to severe bronchiolitis.

Dataset Information

Cross-sectional analysis on publication status and age representation of clinical studies addressing mechanical ventilation and ventilator-induced lung injury in infants and children.

Objectives

Setting

Primary and secondary outcome measures

Results

Conclusions

Publications

Cross-sectional analysis on publication status and age representation of clinical studies addressing mechanical ventilation and ventilator-induced lung injury in infants and children.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets