Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal

Status Completed

Clinical Trial Summary

Non-invasive respiratory support has been emerging in the management of respiratory distress syndrome (RDS) in preterm infants to minimise the risk of lung injury. Intermittent positive pressure ventilation (NIPPV) provides a method of augmenting continuous positive airway pressure (CPAP) by delivering ventilator breaths via nasal prongs.It may increase tidal volume, improve gas exchange and reduce work of breathing. However, NIPPV may associate with patient-ventilator asynchrony that can cause poor tolerance and risk of intubation. It may also in increased risk of pneumothorax and bowel perforation because of increase in intrathoracic pressure. On the other hand, neurally adjusted ventilatory assist (NAVA) is a newer mode of ventilation, which has the potential to overcome these challenges. It uses the electrical activity of the diaphragm (EAdi) as a signal to synchronise the mechanical ventilatory breaths and deliver an inspiratory pressure based on this electrical activity. Comparing NI-NAVA and NIPPV in preterm infants, has shown that NI-NAVA improved the synchronization between patient and ventilator and decreased diaphragm work of breathing . There is lack of data on the use of NI-NAVA in neonates post extubation in the literature. To date, no study has focused on short-term impacts. Therefore, it is important to evaluate the need of additional ventilatory support post extubation of NI-NAVA and NIPPV and also the risk of developing adverse outcomes. Aim: The aim is to compare NI-NAVA & NIPPV in terms of extubation failure in infants< 32 weeks gestation. Hypothesis: Investigators hypothesized that infants born prematurely < 32 weeks gestation who extubated to NI-NAVA have a lower risk of extubation failure and need of additional ventilatory support.

Clinical Trial Description

Study Design: Randomised controlled trial Study Setting: single center NICU level III, KFAFH tertiary care center , Jeddah Saudi Arabia ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03388437
Study type	Interventional
Source	King Fahad Armed Forces Hospital
Contact
Status	Completed
Phase	N/A
Start date	May 1, 2017
Completion date	April 30, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03909854` - Pragmatic Investigation of Volume Targeted Ventilation-1	N/A
Recruiting	`NCT03662438` - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)	N/A
Recruiting	`NCT05308719` - Nasal Oxygen Therapy After Cardiac Surgery	N/A
Recruiting	`NCT05535543` - Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
Completed	`NCT04030208` - Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation	N/A
Recruiting	`NCT04542096` - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting	`NCT04668313` - COVID-19 Advanced Respiratory Physiology (CARP) Study
Recruiting	`NCT05883137` - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed	`NCT04505592` - Tenecteplase in Patients With COVID-19	Phase 2
Completed	`NCT03943914` - Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.	N/A
Active, not recruiting	`NCT03472768` - The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
Not yet recruiting	`NCT04538469` - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting	`NCT02542423` - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.	N/A
Completed	`NCT02265198` - Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome	N/A
Completed	`NCT02105298` - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)	N/A
Completed	`NCT01885442` - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients	N/A
Completed	`NCT01659268` - Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins	N/A
Completed	`NCT02814994` - Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients	N/A
Terminated	`NCT01333059` - Cycling of Sedative Infusions in Critically Ill Pediatric Patients	N/A
Completed	`NCT01249794` - Non Invasive Ventilation After Cardiac Surgery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms