Diaphragm Electrical ActivityNCT06163183
Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children?
An observational study of Diaphragm Electrical Activity and Neurally Adjusted Ventilatory Assist, run by Mersin University.
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. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Diaphragm Electrical Activity, Neurally Adjusted Ventilatory Assist, Pediatrics
- What is being tested?
- Edi catheter
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 30 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- • 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
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- 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
Who cannot join
- • 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.
About this study
Official title: The Potential of Diaphragm Electrical Activity Monitoring to Predict Extubation Success in Children Requiring Mechanical Ventilation Support Due to Respiratory Failure
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.
Read the 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.
- Being tested
- Edi catheter
- Keywords
- pediatrics, extubation success, Diaphragm electrical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edi catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Extubation failure | Not described Receives: Device: Edi catheter | |
| Extubation success | Not described Receives: Device: Edi catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 days
Mechanical ventilatory monitoring
ventilatory parameters (Edi peak, Edi min, FiO2), were recorded during the follow up.
Measured: up to 2 days
Secondary outcomes (3)
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.
Measured: 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))
Vital signs recorded by pediatric intensive care nurses.
Measured: up to 2 days
Expiratory tidal volume
Patients who had >5ml/kg expiratory tidal volume considered to be ready for extubation
Measured: From spontaneous breathing trial until the time for extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Aug 2014
- Primary completion30 Jul 2015
- Study completion30 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragm Electrical ActivityStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edanur Yesil, MD, Mersin University
- Investigators
- Nilufer Yalindag-Ozturk, Proffessor, Study director, Marmara University Medical Faculty, Pediatric Intensive Care Speacilist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163183
- Sponsor's protocol ID
- 1400124188
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, will be shared in publication study
Publications
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.
PubMed 34774209
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Diaphragm Electrical Activity Monitoring to Predict Extubation Success in Children Requiring Mechanical Ventilation Support Due to Respiratory Failure
- ClinicalTrials.gov ID
- NCT06163183
- Acronym / sponsor ID
- 1400124188
- Keywords
- pediatrics, extubation success, Diaphragm electrical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Jul 2015 (actual)
- Study completion
- 30 Jul 2015 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation failure | – | Device: Edi catheter |
| Extubation success | – | Device: Edi catheter |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (11 listed)
- • Aged between one month and 18 years old
Key exclusion criteria (4 listed)
- • Contraindication for the insertion of the nasogastric tube (Edi catheter)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edi catheter | Device | Extubation failure, Extubation success |
Primary outcome
Diaphragm electrical activity (Edi) monitoring
Time frame: up to 2 days
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.
Mechanical ventilatory monitoring
Time frame: up to 2 days
ventilatory parameters (Edi peak, Edi min, FiO2), were recorded during the follow up.
3 secondary outcomes
Arterial/capillary blood gases
Time frame: 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))
Time frame: up to 2 days
Expiratory tidal volume
Time frame: From spontaneous breathing trial until the time for extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Results publication: PubMed 34774209Beck 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.
- Individual participant dataSharing planned: Yes. All collected IPD, will be shared in publication study
Related trials for Diaphragm Electrical Activity
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Epidural Spinal Cord Stimulation for Respiratory Recovery in Brain Injury
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Neonatal Diaphragmatic Activity-Linked Extubation Conditions and Timing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilufer Yalindag-Ozturk, Proffessor study director
Marmara University Medical Faculty, Pediatric Intensive Care Speacilist
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Electrical Activity and Neurally Adjusted Ventilatory Assist, run by Mersin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm electrical activity (Edi) monitoring (time frame: up to 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06163183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.