Clinical Trials Logo

Clinical Trial Summary

This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure. It is hypothesized that neonates and infants will have improved respiratory severity score (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased estimated energy expenditure.


Clinical Trial Description

This single center, prospective cohort crossover study will involve mechanically ventilated neonates and infants who are determined to be on stable ventilator settings in either the NAVA or SIMV(PC) + PS modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and energy expenditure. Infants will be screened for stability criteria including: being stable on the ventilator in either SIMV (PC) + PS or NAVA mode, on weaning or unchanged ventilatory support in previous 12 hours, and no need of escalation of ventilatory pressure or rate in prior 12 hours. After screening criteria is met and consent has been obtained, data will be retrospectively collected for 12 hours prior to randomization. After the subject is randomized, the infant will be stabilized and data will be collected for 12 hours in the randomized mode. Data will then be collected for 12 hours afterwards in the crossover mode. Data will be collected in areas of patient demographics, diagnoses, indications for mechanical ventilation, hemodynamic variables and respiratory parameters. While in each mode, the patient will also have indirect calorimetry obtained to determine estimated energy expenditure of each mode. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02518230
Study type Interventional
Source Children's Mercy Hospital Kansas City
Contact
Status Completed
Phase N/A
Start date January 2014
Completion date June 2015

See also
  Status Clinical Trial Phase
Recruiting NCT05904652 - High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties N/A
Completed NCT04030208 - Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation N/A
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT02930525 - Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation N/A
Recruiting NCT02539732 - Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm
Enrolling by invitation NCT02290236 - Monitored Saturation Post-ICU N/A
Completed NCT02056119 - RCT of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit N/A
Terminated NCT01583088 - Early Stage Amyotrophic Lateral Sclerosis Phrenic Stimulation Phase 3
Withdrawn NCT00990119 - High Flow Therapy (HFT) to Treat Respiratory Insufficiency in Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT00741949 - Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF Phase 3
Completed NCT01411722 - Electrical Activity of the Diaphragm During the Weaning Period Phase 2
Recruiting NCT00339053 - Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair Phase 4
Recruiting NCT00187434 - Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP) N/A
Completed NCT02687802 - Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation
Not yet recruiting NCT05906030 - Diaphragm Dysfunction and Ultrasound Perioperatively
Completed NCT03850977 - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Completed NCT02845375 - Effect of Neuromuscular Blockade and Reversal on Breathing Phase 4
Recruiting NCT03309423 - Is Venous to Arterial Conversion (v-TAC) of Blood Gas Reliable in Critical Ill Patients in the ICU? N/A
Completed NCT04115969 - Outcome After Non-invasive Ventilation.