More about the study

Methods

Objective: To reveal and describe the prevalence of demographic background and care provided for patients with PMV in PICUs.

Design: An international point prevalence study in PICU.

Setting: PICUs in multiple countries, including North and South America, and European and Asian countries.

Patients: Patients ≤ 18 years old who are on mechanical ventilation, with > 14 consecutive days (after 37 weeks postmenstrual age) of ventilation for more than 6 hours/day considering invasive ventilation and NIVs, on the day of the study. Patients with short interruptions (< 48 hours) of ventilation during the weaning process as the same episode of ventilation.

Measurements: Demographic data on included patients; their underlining disease and respiratory comorbidity leading/non-leading to PMV (e.g., prematurity, chronic lung disease, congenital heart disease), data on airway access, mechanical ventilation mode and parameters (i.e., invasive vs. non-invasive, other mode of ventilation including FIO2, duration of ventilation days), treatments (drugs used, invasive intravenous lines, feeding tubes), care unit where the patient admitted from prior to the PICU admission (e.g., NICU, general ward, who has been involved in the management), complications of mechanical ventilation will be collected.

Cirdularization: We will collect and record data via an online website case report form (eCRF) link using a secure web application. Each site investigators will have a secured username and password to access the eCRF.

Expecting Sample Size: We plan to conduct the study on isolated days three months apart for two years. We estimate that at least 2-5% of PICU-admitted cases require PMV. We estimate the prevalence of PMV in the PICUs are around 20%, which can give us 200 to 400 cases per study day from 50-100 participating centers.  

FUTURE CONSIDERATIONS

We believe that this study will provide valuable knowledge in regards PMV in critically ill children. This will help determine the need for a standardized approach or guide to those cohorts to lead better outcomes efficiently.

Lay Summary

Scientific advances, population growth, lower mortality, and increasing complexity of diseases have boosted up the number of patients requiring prolonged breathing assistance with mechanical ventilators in the pediatric intensive care units (PICU) in many parts of the developed world. Previous studies also suggest that there is a small group of children who actually need such a high level of support for extended periods of time, utilizing a lot of human and technical resources. We defined children with prolonged mechanical ventilation (PMV) if they required supports with a breathing machine for more than 14 days. We propose an international point prevalence study of children requiring PMV in PICU. We will conduct the study in multiple centers in several different regions, including North and South America, Europe, and Asian countries, with a strong relationship with local physician colleagues. Practice for patients requiring PMV will be examined including the type and size of local PICU, admission and discharge policies, and patient and treatment modalities administered to such patients, types of professionals looking after patients in PMV, types of health care. We anticipate a high variability in practices suggesting a need to further standardize the management of PMV.. Specifically, as an immediate consequence, by comparing and understanding the differences in patient demographics, practice details among PICUs in regards to the background factors of local PICUs and their patients, practitioners will share their way of dealing with such patients. In that way, this study will support the need to generate guidelines and lead to patient care improvement in PICUs.

Objectives and Research Questions

The proposed study has specific objectives and particular research questions. Our population of interest is children under 18 years old who are mechanically ventilated, either being administered invasively or non-invasively, for more than 14 consecutive days as of a particular study date in the PICU. The ventilation can be initiated in the NICU or non-ICU settings, but the patient’s eligible need to be in the PICU as of the study date. The main goal of this study is to reveal and describe the prevalence of demographic background and care provided for patients requiring PMV in the PICU cohort.

Our study population may include two different cohorts; (a) patients who might need tracheostomy and/or transition to a long course of mechanical ventilation and (b) patients who is on PMV from his/her previous clinical course and re-admit to the PICU due to a concomitant disease or complications related to PMV. We will collect the data which can be associated with potential problems in the two cohorts and be able to be used for the future arguments in the care/practice for those patients (see the following Objectives for more details). We also hypothesize that there are significant discrepancies in prevalence of PMV between countries and their PICUs, including characteristics of the PICUs themselves. Moreover, it can be hypothesized that there are gaps between knowledge and practice in the management of PMV, such as in the tracheostomy practice in PICUs.

Objectives:

  1. To describe the demographic background and care provided for patients with PMV in PICUs.
  2. To explore the differences in prevalence of PMV between countries and their PICUs, including characteristics of the PICUs themselves.
  3. To examine the gap between knowledge and practice in the management of PMV, including tracheostomy practice.
  4. To identify the current healthcare burden both from healthcare side and family side for the patients with PMV, especially for the patients who were already tracheostomized or on PMV prior to the PICU admission.

Research questions:

  1. What is the prevalence of children requiring PMV and their underlining etiologies/ diseases in PICUs?
  2. By whom are the children requiring PMV managed in PICUs and what kind of resources are available/provided in PICUs for these children?
  3. What is the outcome (i.e., Mortality in PICU and hospital, tracheostomy) of the children requiring PMV?
  4. Is there any difference between countries, regions, or PICUs, regarding RQ. 1, 2, and 3?

Additional questions

  1. Is there any difference between the actual practice of the children requiring PMV in PICUs and the knowledge or ideal practice in PICU physicians?
  2. What are the differences in prevalence and characteristics between the patients requiring MV for 14 days and 21 days?
  3. What are the reasons why children requiring PMV unable to be extubated or to transitioning to the care in chronic setting with/without tracheostomy?
  4. What is the current healthcare burden both from healthcare side and family side for the patients who were already tracheotomized and on PMV prior to the PICU admission?
  5. What is the common complication(s) in the ventilator management of children requiring PMV?

Significance of this project

Based on the results of this study, we would determine the need for further study with the aim to establish of best possible practices for management of PMV with respect to quality improvement and best way of translating the evidence to the bedside practice. Specifically, by comparing and understanding the differences in patient demographics, practice details among PICUs in regards to the background factors of PICUs and patients (e.g., cardiac unit, number of beds, nursing care ratios), practitioners can recognize the practice of other intensivists/PICUs and analyze their own practice model and look for the best evidence to promote changes based on best evidence in their future practice. As we have conducted a cross-sectional survey study regarding the tracheostomy practice in PICU patients in Canada, by examining/comparing the results, we could identify a knowledge gap between actual practice and the knowledge we hold. This can help us to find the best approach in each situation as well.

We believe that this study will provide valuable knowledge in regards to PMV in critically ill children. This will help us to determine the need for a standardized approach or guide for PMV patients. We would stress that the information gathered will be central to determine standards of care and plan best use of resources allocation and to evaluate for the current management of PMV patient. Particularly, by understanding the prevalence of the patients with PMV in the current PICUs, we could narrow down and aim at issues we need to sort out as next steps.

Summary methods

Study designs

An international point prevalence prevalence study in PICUs on the observed current local practice pattern for patients receiving PMV in regard to and patients’ clinical and demographic backgrounds of children with PMV.

Screening and employment

Population

All critically ill children in participating PICU will be considered for eligibility. Patients who are managed outside of the participating PICUs such as different facilities or other units in the participating centers are out of scope for this study. The patients who supposed to be in the red colored area will be our scope of population.

Screening of elligible patients

The site investigator or the research assistant will screen for candidates in the PICU as close as possible to 9 am on the study date. An eligibility screening log, documenting the subject’s fulfillment of the entry criteria, will be completed for all eligible patients considered for the study, regardless of their subsequent inclusion or exclusion status.

Elligible patients

All patients on invasive or non-invasive mechanical ventilation on the day of the study or patients who had been on InMV or non-invasive ventilation (NIVs) during their PICU stays will be eligible. Patients who fulfill inclusion criteria and do not meet any exclusion criteria will be considered for inclusion in the study.

Inclusion criteria

Patients who are ventilated >14 consecutive days (after 37 weeks postmenstrual post-conception age), including for more than 6 hours per day including on InMV and NIV duration; patient who have had and short interruptions (<48hours) of ventilation during the weaning process as the same episode of ventilation can be included (16). InMV can be administered through an endotracheal tube or a tracheostomy tube. NIV can be managed through a nasal, full-face, total facial mask, or helmet. Patient on HFNC will be included as on respiratory support if they have a proper or a nasal cannula (that allows >=1 liters/kg/min (LPM) and >4LPM). We define nasal oxygen supply <1 L/kg/min as non-NIV practice. The inclusion criteria will be examined at 9 a.m. on the day of the study. All types of ventilators are accepted, including high-frequency ventilators. For neonates, only consecutive days after 37 weeks postmenstrual age will be taken into account (16).

Exclusion criteria

  • Age >18 years
  • Already included in this study
  • No consent if required
  • Brain death
  • Premature children not yet at 37 weeks gestational age

Collection of data for each patient

The data will be collected on the patients on a single occasion as close as possible to 9 am on the day of the study. The data can be collected retrospectively from the patient’s PICU chart. The data collection will take eight times during the two-year study period, which can cover the potential seasonal variability patients. We will collect the outcome data (i.e., 90 days mortality, PICU stay or not, Hospital stay or not, Tracheotomised or not) including the duration of MV.

Data management

A screening log (documenting the subject’s fulfillment or not of the entry criteria) of all mechanically ventilated children will be registered, involving even those patients who will not be enrolled in the study. A report form will be developed using the platform of the Biomedical Telematic Laboratory of the Respiratory Health Network of the “Fonds de Recherche en Santé du Québec” (LTB-RHN), with the appropriate safeguards for confidentiality. Site investigators (physicians responsible for this study in each study site and research assistants) will have access to the system only to enter their own data. This link will give them access only to the patients they visualize their particular data entered, not the whole data or from other centers. Hence, the steering committee members will be the only ones to have access to the complete database.

Confidentiality will also be ensured by many measures with respect to the database. The report will be as an anonymous form and will be used exclusively for the aims presented above. The anonymous LTB-RHN database will be stored for a minimum of 10 years.

The database analysis for the main study will be performed by AK with Stata version 13® (Stata Corp LP, 2013) or other relevant statistical software using computers and servers electronically protected. Access to the database will be controlled by passwords that are changed periodically; data are encrypted during transfer; daily backup of the full database will be conducted.

Sponsor and Funding Sources

This study is supported by:
Réseau en Santé Respiratoire du Québec (Quebec Respiratory Health Network),
Fonds de la recherche en santé du Québec (FRQS)
Women and Children Health Research Institute (WCHRI) – Clinical/Community Research Integration and Support Program
Réseau mère-enfant de la francophonie

  • RMEF