Clinical trial NCT06163183: Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children?
Official title: The Potential of Diaphragm Electrical Activity Monitoring to Predict Extubation Success in Children Requiring Mechanical Ventilation Support Due to Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm Electrical Activity
Neurally Adjusted Ventilatory Assist
Pediatrics
Keywords: pediatrics
extubation success
Diaphragm electrical activity
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The majority of the patients were under 18 months of age (median 18 months, between 2 and 204 months) and 60% (n=15) were female.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diaphragm electrical activity (Edi) monitoring
timeFrame: up to 2 days
measure: Mechanical ventilatory monitoring
timeFrame: up to 2 days
Secondary outcomes:
measure: Arterial/capillary blood gases
timeFrame: 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.
measure: Vital signs ((fever, heart rate (HR), respiratory rate (RR), tension arterial))
timeFrame: up to 2 days
measure: Expiratory tidal volume
timeFrame: From spontaneous breathing trial until the time for extubation
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University Medical Faculty, Pediatric Intensive Care Speacilist
name: Nilufer Yalindag-Ozturk, Proffessor
role: STUDY_DIRECTOR
References:
citation: Beck J, Sinderby C. Neurally Adjusted Ventilatory Assist in Newborns. Clin Perinatol. 2021 Dec;48(4):783-811. doi: 10.1016/j.clp.2021.07.007. Epub 2021 Oct 2.