Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163183
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2023-11-27
Brief Title:
Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children
Sponsor:
Mersin University
Organization:
Mersin University
Study Overview
Official Title:
The Potential of Diaphragm Electrical Activity Monitoring to Predict Extubation Success in Children Requiring Mechanical Ventilation Support Due to Respiratory Failure
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients parents and ethical approval from the Marmara University Faculty of Medicine Scientific Research Ethics Committee Board on 06092014 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 Arterialcapillary 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
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 Arterialcapillary 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None