Tracheal dilatation using the study device as per the protocol.

Tracheal Stenosis

Airway Disease

Pediatric Respiratory Diseases

'Tracheolator' non-occlusive tracheal dilation balloon manufactured by Disa Life Sciences, Cape Town, South Africa.

Tracheolator

Groote Schuur Hospital

Endotracheal Dilator to Improve Oxygenation

Modified Endotracheal Balloon Dilator to Improve Oxygenation During Airway Procedures in Children With Tracheal Stenosis

Post-dilation change from pre-dilatation values, measured using Myer-Cotton grade and millimeter value

Oxygen saturation nadir as determined by plethysmography

Change from pre- and post-dilatation values, measured using Myer-Cotton grade and millimeter value

The data set will be published after study completion using a medium still to be determined. Data set will be available to other researchers on request.

Ross Hofmeyr

Associate Professor, Dept Anaesthesia & Perioperative Medicine

University of Cape Town

Red Cross War Memorial Children's Hospital

Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.

Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure

Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask

Usual Care

Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.

Non Invasive Ventilation Via Helmet

Total

Sex: Female, Male

Race (NIH/OMB)

Number of patients requiring endotracheal intubation after application of helmet device

Need for Endotracheal Intubation

Days spent in hospital at time of enrollment

Hospital Length of Stay

Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)

Number of Participants Functional Status After Discharge

Duration of mechanical ventilation via endotracheal tube

Ventilator-free Days

Death from any cause during hospitalization at time of enrollment

Hospital Mortality

Number of days admitted to a medical intensive care unit

Intensive Care Unit Length of Stay

ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness

ICU Complications

Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment

Readmission to the Intensive Care Unit

Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to

Discharge Location

Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100

Improvement of Oxygenation

Overall Study

John P. Kress

Acute Respiratory Distress Syndrome

Shock

Ventilatory Failure

Cardiogenic Pulmonary Edema

Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.

Non invasive ventilation using a helmet hyperbaric device

Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask

tracheal stenosis/hypoxia

Endotracheal Dilator to Improve Oxygenation

Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure

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