Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children?

Pediatrics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06163183
• Other study ID #: 1400124188
• Status: Completed
• Start date: August 1, 2014
• Est. completion date: July 30, 2015

Study information

• Verified date: December 2023
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 30, 2015
• Est. primary completion date: July 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diaphragm Electrical Activity
• Neurally Adjusted Ventilatory Assist
• Pediatrics

Intervention

Device:
• Edi catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm electrical activity (Edi) monitoring	Macquet (servo-i) mechanical ventilator measures the electrical activity (Edi) of the diaphragm (microvolts). Edi signals are measured using special feeding tubes (Edi catheter) equipped with tiny sensors at the level of gastroesophageal junction. In the ventilator, Edi trend values can be monitored continuously as 24-hour records.	up to 2 days
Primary	Mechanical ventilatory monitoring	ventilatory parameters (Edi peak, Edi min, FiO2), were recorded during the follow up.	up to 2 days
Secondary	Arterial/capillary blood gases	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.	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.
Secondary	Vital signs ((fever, heart rate (HR), respiratory rate (RR), tension arterial))	Vital signs recorded by pediatric intensive care nurses.	up to 2 days
Secondary	Expiratory tidal volume	Patients who had >5ml/kg expiratory tidal volume considered to be ready for extubation	From spontaneous breathing trial until the time for extubation