Positive Pressure Ventilation and Sternal Closure in HLHS

NCT02455713 | Withdrawn

• 1 other identifier: 1000047473
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the cardiopulmonary interactions that occur with increasing ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left heart syndrome before and after sternal closure. Outcome measures include oxygen delivery and cardiac output.

Conditions

Hypoplastic Left Heart Syndrome

Outcome Measures

Primary Outcomes (1)

• Oxygen Delivery calculated from direct measurements of oxygen consumption via respiratory mass spectrometry

  Oxygen delivery will be calculated from direct measurements of oxygen consumption via respiratory mass spectrometry and estimates of cardiac output calculated using the Fick equation from measured arterial a venous blood gas samples.

  Measurements made 15 minutes after each ventilator change. Total duration of observation is 2.5 hours.

Secondary Outcomes (1)

• Cardiac Output calculated using the Fick Equation

  Measurements made 15 minutes after each ventilator change. Total duration of observation is 2.5 hours.

Study Arms (1)

Intervention

Alter PEEP and PIP and measure hemodynamic outcomes.

Device: PEEP and PIP

Interventions

PEEP and PIP DEVICE

Changing ventilator settings and measuring oxygen delivery and cardiac output

Intervention

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants after congenital heart surgery.

You may qualify if:

• \. All patients who, following stage 1 palliation for single ventricle physiology, undergo delayed sternal closure are eligible to be included in the study

You may not qualify if:

• History of pneumothorax, acute respiratory distress syndrome, or other contraindication to the proposed ventilator manipulations as determined by the responsible CCCU staff physician.
• Endotracheal tube leak \> 15%.
• Lack of informed consent from parents.
• Weight less than 2.6kg

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Steven Schwartz, MD

  The Hospital for Sick Children, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Paediatrics

Study Record Dates

• First Submitted: April 5, 2015
• First Posted: May 28, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

CA (1)