Advertisement

Topics

Helmet Continuous Positive Airway Pressure Support for Severe Bronchiolitis in PICUs

2016-12-01 16:08:22 | BioPortfolio

Summary

Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25 patients at least.

- 10 cmH2O peep, 50 L/min gas flow, fraction of inspired oxygen (FiO2) 0.5 on PICU admission (random 1)

- 5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and respiratory worsening, reduction of pH or partial oxygen arterial pressure (PaO2)/FiO2 occurs in the following first hour after Helmet CPAP treatment start, patients enrolled will receive endotracheal intubation, full face mask non invasive ventilation or higher peep level treatment (7.5-10 cmH2O) according to clinical evaluation, if necessary.

In investigator's experience, early worsening of severe bronchiolitis in PICU in the first hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.

Description

INTRODUCTION

Newborns and infants with severe bronchiolitis admitted in PICU (Pediatric Intensive Care Unit) are patients at high risk for invasive mechanical ventilation support. In current literature, there is lack of multicenter, prospective and randomized studies to assess and describe the impact of non invasive ventilation support among severe bronchiolitis admitted in PICU, notwithstanding the actual improvement of non invasive ventilation technique on intubation rate reduction.

Recently, we can find studies on bronchiolitis management in pediatric ward and supported with high flow nasal cannula (HFNC).

The studies on severe bronchiolitis admitted in PICU do not evaluate positive end expiratory pressure (Peep) level applied during Helmet continous positive airway pressure (CPAP) support.

According to Italian PICU Network (TIPNET) data, severe bronchiolitis admitted in PICU intubation rate is close to 10% (report 2010-2016), whatever non invasive ventilation support has been used.

Principal investigators have performed a retrospective and cohort chart review among severe bronchiolitis (82) admitted in PICU from 2011 to 2015. Early Helmet CPAP was applied to patients, but peep level has been provided according to clinician experience, because of lack of indication on this issue. Patients were admitted in PICU from Emergency department, pediatric ward and up to 72 hours of ineffective HFNC support. The investigators have studied intubation rate, length of stay, bronchiolitis severity score, virus infection, peep level and gas flow applied on Helmet CPAP.

According to preliminary results, 10 cmH2O peep level results 50 time more protective than lower (5-7.5 cmH2O) peep among flow rate of 50 L/min.

Intubation rate with peep level 10 cmH2O was 3%, while it rose over 15% among 7.5-5 cmH2O peep level. Statistically significant difference were found on length of PICU stay.

Scientific literature on Helmet CPAP noising exposure is poor. Such noising was proved to be reduced with filter application on Helmet CPAP respiratory circuit. There are not report, and we have never experienced acoustic system impairment in patients undergone Helmet CPAP.

AIMS Primary aim: to evaluate intubation rate on severe bronchiolitis admitted in PICU and supported with Helmet CPAP non invasive ventilation with 10 cmH2O peep level in group 1, and 5 cmH2O peep level in group 0.

Secondary aim: to evaluate, among two study groups, length of PICU stay, pneumothorax incidence on Helmet CPAP, sedation effect during Helmet CPAP, early enteral feeding tolerance, syncytial and other respiratory virus incidence, bacterial infection and 30 days outcome.

DESIGN Prospective, randomized, cohort, controlled and multicentric study.

Population: sample size The study requires 488 patients, enrolled among 20 national and international PICU. Sample size have been calculated on preliminary results of our retrospective chart review; we hypothesize that intubation rate with 5 cmH2O peep level is 15% and application of 10 cmH2O peep level may reduce it to 50%. According to these hypothesis, we need 244 patients for each group to have 5% of significativity level and 80% of study power.

Length of study 24 months

Procedure and methods

Selection and patient enrollment Severe bronchiolitis admitted in PICU and requiring respiratory support.

Intervention

Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25 patients at least.

- 10 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 1)

- 5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and respiratory worsening, reduction of pH or PaO2/FiO2 occurs in the following first hour after Helmet CPAP treatment start, patients enrolled will receive endotracheal intubation, full face mask non invasive ventilation or higher peep level treatment (7.5-10 cmH2O) according to clinical evaluation, if necessary.

In investigators' experience, early worsening of severe bronchiolitis in PICU in the first hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.

STUDY PLAN Application of a standard treatment protocol for all patients enrolled. It is the same standard of care applied to treat these patients in our PICU in the last 2 years. Of course, patients who will not be enrolled in the study will be supported and treated with the best feasible care.

- Registration of the modified Wood's Clinical Asthma score (mWCAS) for severe bronchiolitis admitted in PICU (Bronchiolitis Severity Score-BSS)

- clarithromycin prophylaxis for newborns (up to 30 days old), or I generation cephalosporine for older infants, if high fever, lung opacities or high inflammation markers occurs (PCR, procalcitonin, White body cells)

- volume replacement (20 ml/kg of sodium chloride solution or albumine 5%) in 60 min

- morphine ev bolus: 20 mcg/kg in 2 min and following 5 mcg/kg/h infusion (or other sedatives according to local PICU investigator)

- nasogastric tube placement and early enteral feeding 4-6 hours after admission (5-10 ml/h)

- desamethasone 0.2 mg/kg x3/die ev (according to local PICU investigator ).

- proton pump inhibitors or H2 receptor antagonist (according to local PICU investigator).

- aerosol therapy 4 time/die: sodium chloride hypertonic solution 3% (or sodium chloride 0.9%) 2 ml with ipratropium bromide .

- Arterial blood gas exam (ABE) before Helmet CPAP application and in the following 1,12 24, and 48 hours; arterial catheter positioning is preferred (or arterial blood sampling by direct arterial puncture according to local PICU practice).

- Pharyngeal swab for molecular analysis to detect viral DNA will be performed on PICU admission, if not yet performed.

- occipital and neck skin protection will be used to avoid Helmet CPAP pressure sores.

- each Helmet will be provided of a filter to reduce noise inside it.

- Helmet gas will flow through heat-moisture device switched on 5 min/hour

Only patients whose parents have signed written informed consent will be enrolled in this study. Any direct follow up is supposed after PICU discharge. Monitoring of hospital discharge will be followed by intranet database of the participant hospital.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Critically Ill Severe Bronchiolitis

Intervention

10 cmH2O peep

Location

Bambino Gesù Children's Hospital
Rome
Lazio
Italy
00100

Status

Recruiting

Source

Bambino Gesù Hospital and Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-01T16:08:22-0500

Clinical Trials [408 Associated Clinical Trials listed on BioPortfolio]

Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis

Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway inflammation increases the respiratory system resistances and dynamic hyperinflation. This leads to a...

Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II

The main objective of the APW-RSV II clinical trial is to evaluate if the addition of azithromycin to routine bronchiolitis care, among infants hospitalized with RSV bronchiolitis, reduces...

Suspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia

For some upper ureteral and renal stones,ureteroscopic lithotripsy needs to be performed under general anesthesia with interrupted suspension of mechanical ventilation, which could result ...

Expiratory Flow Limitation and Mechanical Ventilation During Cardiopulmonary Bypass in Cardiac Surgery

During general anesthesia a reduction of Functional Residual Capacity (FRC) was observed. The reduction of FRC could imply that respiratory system closing capacity (CC) exceeds the FRC and...

Single Dose of Furosemide to Improve Respiratory Distress in Moderate to Severe Bronchiolitis

The purpose of this study is to assess if administration of an early single dose of a diuretic (furosemide) to children with moderate to severe bronchiolitis can reduce extravascular lung ...

PubMed Articles [6075 Associated PubMed Articles listed on BioPortfolio]

Extrapolation of a non-linear autoregressive model of pulmonary mechanics.

For patients with acute respiratory distress syndrome (ARDS), mechanical ventilation (MV) is an essential therapy in the intensive care unit (ICU). Suboptimal PEEP levels in MV can cause ventilator in...

Pre-birth cohort study of atopic dermatitis and severe bronchiolitis during infancy.

Infants hospitalized for bronchiolitis (i.e., severe bronchiolitis) are at increased risk of childhood asthma. There are many known risk factors for severe bronchiolitis, including cardiac and pulmona...

Effect of PEEP, blood volume, and inspiratory hold maneuvers on venous return.

According to Guyton's model of circulation, mean systemic filling pressure (MSFP), right atrial pressure (RAP), and resistance to venous return (RVR) determine venous return. MSFP has been estimated f...

A Regional Cohort Study of the Treatment of Critically Ill Children with Bronchiolitis.

To describe the treatment practices in critically ill children with RSV bronchiolitis across four regional PICUs in the northeastern United States, and to determine the factors associated with increas...

Should PEEP Titration Be Based on Chest Mechanics in Patients With ARDS?

Functional residual capacity (FRC) is essentially the alveolar volume and a determinant of both oxygenation and respiratory system compliance (CRS). ARDS decreases FRC, and sufficient PEEP restores FR...

Medical and Biotech [MESH] Definitions

Non-therapeutic positive end-expiratory pressure occurring frequently in patients with severe airway obstruction. It can appear with or without the administration of external positive end-expiratory pressure (POSITIVE-PRESSURE RESPIRATION). It presents an important load on the inspiratory muscles which are operating at a mechanical disadvantage due to hyperinflation. Auto-PEEP may cause profound hypotension that should be treated by intravascular volume expansion, increasing the time for expiration, and/or changing from assist mode to intermittent mandatory ventilation mode. (From Harrison's Principles of Internal Medicine, 12th ed, p1127)

Inflammation of the BRONCHIOLES.

Health care provided to a critically ill patient during a medical emergency or crisis.

Inflammation of the BRONCHIOLES leading to an obstructive lung disease. Bronchioles are characterized by fibrous granulation tissue with bronchial exudates in the lumens. Clinical features include a nonproductive cough and DYSPNEA.

An acute inflammatory disease of the upper RESPIRATORY TRACT, caused by paramyxoviruses, occurring primarily in infants and young children; the viruses most commonly implicated are PARAINFLUENZA VIRUS TYPE 3; RESPIRATORY SYNCYTIAL VIRUS, HUMAN; and METAPNEUMOVIRUS.

More From BioPortfolio on "Helmet Continuous Positive Airway Pressure Support for Severe Bronchiolitis in PICUs"

Quick Search
Advertisement
 

Relevant Topics

Respiratory
Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial