Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children?

NCT06163183 | Completed

• 1 other identifier: 1400124188
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diaphragm Electrical Activity; Neurally Adjusted Ventilatory Assist; Pediatrics

Keywords

pediatrics; extubation success; Diaphragm electrical activity

Outcome Measures

Primary Outcomes (2)

• 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

• Mechanical ventilatory monitoring

  ventilatory parameters (Edi peak, Edi min, FiO2), were recorded during the follow up.

  up to 2 days

Secondary Outcomes (3)

• Arterial/capillary blood gases

  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.

• Vital signs ((fever, heart rate (HR), respiratory rate (RR), tension arterial))

  up to 2 days

• Expiratory tidal volume

  From spontaneous breathing trial until the time for extubation

Study Arms (2)

Extubation failure

Device: Edi catheter

Extubation success

Device: Edi catheter

Interventions

Edi catheter DEVICE

Extubation failure; Extubation success

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Related 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.

  PMID: 34774209 RESULT

Study Officials

• Nilufer Yalindag-Ozturk, Proffessor

  Marmara University Medical Faculty, Pediatric Intensive Care Speacilist

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 8, 2023
• Study Start: August 1, 2014
• Primary Completion: July 30, 2015
• Study Completion: July 30, 2015
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 4 month
• Access Criteria: After publication of study, the study will be shown by request.