Clinical Trials Directory

Trials / Completed

CompletedNCT06163183

Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children?

The Potential of Diaphragm Electrical Activity Monitoring to Predict Extubation Success in Children Requiring Mechanical Ventilation Support Due to Respiratory Failure

Status
Completed
Phase
Study type
Observational
Enrollment
25 (actual)
Sponsor
Mersin University · Academic / Other
Sex
All
Age
2 Months – 17 Years
Healthy volunteers
Not accepted

Summary

This study aimed to record diaphragm electrical activity (Edi) during the preextubation (weaning) and postextubation periods and to analyze whether Edi monitoring could predict extubation success.

Detailed description

This prospective observational study included 25 pediatric patients who were intubated due to respiratory failure in the pediatric intensive care unit of the tertiary university-affiliated Marmara University Hospital between August 2014 and July 2015. To conduct the study, we obtained informed consent from the patient's parents and ethical approval from the Marmara University Faculty of Medicine Scientific Research Ethics Committee Board on 06.09.2014. Pediatric patients included which had indication for the insertion of a nasogastric tube (Edi catheter), independent of the study. So Edi catheter had been used instead of nasogastric tube. When the patients were ready for clinical weaning in accordance with the clinician, the Edi catheter was appropriately inserted into the patients. Then, a spontaneous breathing trial (SBT) was performed and diaphragm activity monitoring was recorded during this process. The patients who met the inclusion criteria switched in a spontaneous breath trial with pressure support ventilation (PSV) or NAVA (Neurally Adjusted Ventilatory Assist) on a Maquet (Solna, Sweden) Servo-i mechanical ventilator for both ventilation modes The patients' demographic and clinical characteristics, mortality scoring, vital parameters (HR, TA, SpO2, RR) and ventilatory parameters (Edi peak, Edi min, FiO2, expiratory Vt), as well as follow-up period were recorded. Arterial/capillary blood gases were taken within the last four hours before extubation and within the first, sixth, 12th, 18th and 24th hours after extubation. If arterial blood gas monitoring was initiated in the patient, arterial monitoring was continued. If capillary blood gas monitoring was initiated, capillary monitoring was continued. Edi data were recorded for at least 24 hours before and after extubation. Edi values were obtained retrospectively from the trend diagram, which provides 24-hour continuous records on the ventilator screen.

Conditions

Interventions

TypeNameDescription
DEVICEEdi catheter

Timeline

Start date
2014-08-01
Primary completion
2015-07-30
Completion
2015-07-30
First posted
2023-12-08
Last updated
2023-12-08

Source: ClinicalTrials.gov record NCT06163183. Inclusion in this directory is not an endorsement.