ClinicalTrials.Veeva

Menu

Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children?

M

Mersin University

Status

Completed

Conditions

Pediatrics
Neurally Adjusted Ventilatory Assist
Diaphragm Electrical Activity

Treatments

Device: Edi catheter

Study type

Observational

Funder types

Other

Identifiers

NCT06163183
1400124188

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

2 months to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • • Aged between one month and 18 years old

    • Intubated for more than 48 hours due to respiratory failure

    • Indication for the insertion of a nasogastric tube (Edi catheter), independent of the study

    • Ready for weaning:

      • Normal vital signs for age (fever, heart rate (HR), respiratory rate (RR), tension arterial (TA)
      • No catecholamines or sedation drugs
      • pH of 7.35 to 7.45
      • Positive end expiratory pressure (PEEP) ≤6 mmHg
      • Fractionated oxygen (FiO2) ≤0.5
      • Oxygen saturation (SpO2) ≥92%
      • Vt≥ 5 ml/kg

Exclusion criteria

  • • Contraindication for the insertion of the nasogastric tube (Edi catheter)

    • Patients treated with muscle relaxants
    • Absence of consent given by the patient's family
    • Cases whose Edi levels could not be taken from ventilator's trend diagram due to missing values.

Trial design

25 participants in 2 patient groups

Extubation failure
Treatment:
Device: Edi catheter
Extubation success
Treatment:
Device: Edi catheter

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems