Ancillary studies

The following four ancillary studies and the CRFs are considered as ancillary questions to the main study and its CRF. All the participating centers to the main study will be asked if they agree or disagree to participate in the ancillary study (i.e., either participating in the four studies or not).

Study one: NICU Graduate

Specific leads: A Fernández and Y López-Fernández

Objectives

  1. To determine the clinical course and outcomes in infants on PMV admitted to PICU from their previous clinical course (NICU).
  2. To identify factors associated with prolonged mechanical ventilation in infants transitioned from NICU to PICU.

Study two: Sedation and Neurological Condition

Specific leads: GG Guerra1, JH Lee, M Kneyber

Objectives

  1. To describe the use of sedation and analgesia drugs in children who received PMVed including LTVed (i.e., chronically ventilated children ventilated >90days) patients.
  2. To describe the use of physical restrains in PMVed patients in PICU.
  3. To describe the incidence of delirium in PMVed patients in PICU.
  4. To describe the incidence of withdrawal symptoms in PMVed patients in PICU.
  5. To describe the level of mobilization in PMVed patients in PICU.
  6. To compare the use of sedation/analgesia drugs, and the incidence of withdrawal symptoms and delirium between tracheotomised and intubated patients.
  7. To compare long-term neurocognitive, adaptive behavior outcomes and health related quality of life in chronically ventilated children.

1 Gonzalo Garcia Guerra: Department of Pediatrics, University of Alberta, Edmonton Canada.

Study three: Practice of ventilator settings

Specific leads: Y Enomoto2, T Kawasaki, F Chiusolo

Objectives

  1. To describe kinds/types of mechanical ventilator settings applied to the patients requiring PMV in PICUs
  2. To examine if there are any difference in the MV settings compared to the initial study date (day0) and the reason for still necessitating the MV, when patients require MV up to the 90th day consecutively from the study inclusion.
  3. To explore inclusion what kinds of ventilator are applied and what MV settings are used, when patients require MV up to the 90th day consecutively from the study.
  4. To examine parameters of MV settings and oxygenation capacity after the acute phase (14 to 20 days of MV) associated with the outcomes (mortality, dependency on MV)

2 Yuki Enomoto: Department of Emergency and Critical Care, University of Tsukuba, Ibaraki Japan.

Study four: Long Term Home Ventilation

Specific leads: M Pons-Odena, R Graham, RG Cortes3

Objectives

  1. Describe the characteristics of pediatric patients who were on Home Mechanical Ventilation (HMV) before this PICU admission with PMV.
  2. Explore the effect of “PICU admission” in HMVed patients.
  3. Describe health care resource including funding system for HMVed patients.
  4. Describe how transition from hospital ventilation to HMV is done in patients who need Home ventilation for first time.
  5. Describe the characteristics and medical conditions of the patients.

3 Rafael Gonzalez Cortes: Gregorio Marañón General University Hospital, Madrid Spain