Mechanical VentilationNCT04788589
Sedation and Ventilator Weaning Protocol in PICU
A study testing Sedation and ventilator weaning protocol in people with Mechanical Ventilation and Sedation, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This research is a single-blinded, randomized controlled trial involving mechanically ventilated children in Pediatric Intensive Care Unit, Cipto Mangunkusumo Hospital, Indonesia. Subjects were divided into two groups: intervention vs control group. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Mechanical Ventilation, Sedation
- What is being tested?
- Sedation and ventilator weaning protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2020to 1 Jul 2022
- Phase
- Interventional
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient who need mechanical ventilation for more than 12 hours
Who cannot join
- PICU admission due to post cardiac and respiratory arrest
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Effectiveness of Sedation and Ventilator Weaning Protocol - a Randomized Controlled Trial
This research is a single-blinded, randomized controlled trial involving mechanically ventilated children in Pediatric Intensive Care Unit, Cipto Mangunkusumo Hospital, Indonesia. Subjects were divided into two groups: intervention vs control group. Primary and secondary outcomes will be measure pre, during, and post treatment.
Read the detailed description
As of today, there is no sedation and ventilator weaning protocol in our PICU. Decision for sedation and ventilator weaning were based on attending physicians clinical judgement, which greatly varies among individual. Previous study on the use of these protocols showed a favorable outcome. We aim to assess the safety and effectiveness of this protocol in our PICU.
Subjects were recruited consecutively and randomized into intervention and control group.
- Intervention group: sedation and ventilator weaning protocol
- Control group: no protocol
Primary outcomes:
- FLACC score
- COMFORT score
- Ventilator days
Secondary outcomes:
- Self extubation
- Reintubation
- PICU Length of stay
- Frequency of asynchrony
- NIRS value
- VIS score
- Conditions
- Mechanical Ventilation, Sedation
- Being tested
- Sedation and ventilator weaning protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation and ventilator weaning protocolOther
Subjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before.
| Study group | Role | What they receive |
|---|---|---|
| Sedation and Ventilator Weaning Protocol | Experimental | Sedation: start midazolam 5-10 mins (max 3x). If MV 12 hrs-2d: Pain: morphine @2 hrs if needed (max 10mg/x). Sedation: midazolam @ 1-2 hrs if needed (max 10mg/x). If MV >2 d: morphine \& midazolam drip (max 10mg/hr). MV weaning checklist @morning. Pass if no incr of sedation dose due to agitation, NMBAs, incr in ICP. Fail: reassessed tomorrow. Pain and SBS scores assessed @morning until extubation. Stop all sedation and analgetic for sedation. Continue analgetics for pain. Subjects monitored for 4 hrs. Assess pain and WAT-1 score. Pass (GCS of E3, tolerate sedation interruption for > 4 hrs): MV weaning protocol. Fail (Persistent anxiety/agitation, incr pain score, incr RR > 5 mins, SpO2 <88% >5 mins, acute heart dysrhythmia, >=2 signs of ARDS): sedation resumed ½ dose, up titrated.
MV weaning: CPAP 5/PS < 7. Pass: No failure criteria for 2 hrs. Fail (Incr RR > 5 mins, SpO2 <88% > 5 mins, acute decr in GCS/acute heart dysrhythmia, >=2 signs of ARDS): previous MV setting. Receives: Other: Sedation and ventilator weaning protocol |
| Control | No intervention | 1. Informed consent 2. Randomization into groups 3. Sedation and ventilator weaning according to attending physicians 4. Pain scores and SBS score is noted every 6 hours for the first 24 hours, and every day for the next 24 hours until extubation. 5. Attending physicians assessed that subject could be weaned: pain scores, SBS score, WAT-1 score 6. Extubation. Researcher did not take part in the judgement of extubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Measured: every 6 hours for the first 24 hours, once daily until extubation. This is the baseline. Once the patient was intubated, FLACC scoring of hour 0 will be assessed and noted.
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 6
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Measured: FLACC scoring of hour 6 will be measured 6 hours after hour 0 was measured. Hour 6 is measured from the time the subject was intubated.
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 12
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Measured: FLACC scoring of hour 12 will be measured 12 hours after hour 0 was measured. Hour 12 is measured from the time the subject was intubated.
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 18
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Measured: FLACC scoring of hour 18 will be measured 18 hours after hour 0 was measured. Hour 18 is measured from the time the subject was intubated.
Face, Leg, Activity, Cry, Consolability (FLACC) score day 1 until extubation
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Measured: Scoring will be assessed every morning. If the subject was intubated at night, scoring for day 1 will be measured in the morning the day after tomorrow. Thereafter, the measurement will be taken every morning, 24 hour apart until the subject extubation.
Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Measured: This score will be taken when the subject was stopped from all sedative and analgetics, just before extubation. Monitoring of extubation will be conducted until 56 days after initial intubation.
COMFORT score hour 0
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
Measured: This is the baseline. Once the patient was intubated, COMFORT scoring of hour 0 will be assessed and noted.
COMFORT score hour 6
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
Measured: COMFORT scoring of hour 6 will be measured 6 hours after hour 0 was measured. Hour 6 is measured from the time the subject was intubated.
COMFORT score hour 12
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
Measured: COMFORT scoring of hour 12 will be measured 12 hours after hour 0 was measured. Hour 12 is measured from the time the subject was intubated.
COMFORT score hour 18
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
Measured: COMFORT scoring of hour 18 will be measured 18 hours after hour 0 was measured. Hour 18 is measured from the time the subject was intubated.
COMFORT score day 1 until extubation
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
Measured: Scoring will be assessed every morning. If the subject was intubated at night, scoring for day 1 will be measured in the morning the day after tomorrow. Thereafter, the measurement will be taken every morning, 24 hour apart until the subject extubation.
COMFORT score extubation day
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
Measured: This score will be taken when the subject was stopped from all sedative and analgetics, just before extubation. Monitoring of extubation will be conducted until 56 days after initial intubation.
Ventilator time
Time to extubation (days)
Measured: From intubation to extubation which would not need reintubation within 48 hours of extubation, measurement of the time frame may be assessed up to 28 days measured from intubation time.
Secondary outcomes (9)
Reintubation frequency
Number of times subject was reintubated within 48 hours after extubation
Measured: Frequency of subject who are extubated to be reintubated within 48 hours after extubation. Assessment will be noted up to 28 days measured from the first time intubation was performed.
Self extubation frequency
Number of times subject was self extubated during one episode of intubation
Measured: Frequency of self extubation by the patient during one episode of intubation. Assessment will be noted up to 28 days measured from the first time intubation was performed.
PICU length of stay
Days from PICU admission to death or move outside the PICU to the ward
Measured: Length of stay in PICU from admission until patient's death or step-down to the pediatric ward. Assessment of PICU length of stay will be noted up to 56 days measured from the first day of PICU admission as day 1.
Near infrared spectroscopy minute 5
Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury.
Measured: The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-1
Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury.
Measured: The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-6
Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury.
Measured: The scoring will be noted during hour-6 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-12
Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury.
Measured: The scoring will be noted during hour-12 after sedatives/analgetic administration following intubation.
Inotropic intervention
All inotropes used will be noted as secondary outcome to identify the hypotensive and/or bradycardia complications that might be caused due to usage of sedatives and analgesia. The usage will be divided into two categories: Yes and No usage of inotrope
Measured: The inotropic intervention will be noted throughout PICU admission up to 14 days of mechanical ventilation days.
Vasoactive-Inotropic Score
The VIS were extracted from the formula: dopamine dose (μg/kg/minute) + dobutamine dose (μg/kg/minute) + 100 x epinephine dose (μg/kg/minute) + 10 x milrinone dose (μg/kg/minute) + 10,000 x vasopressine dose (unit/kg/minute) + 100 x norepinefrine dose (μg/kg/minute). The VIS score was categorized into two (≥20 dan <20).
Measured: The VIS score will be measured once during PICU admission up to 14 days of mechanical ventilation days.. The highest value will be recorded and categorized into two groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Sep 2020
- Primary completion1 Jan 2022
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Antonius Hocky Pudjiadi, SpA(K), Universitas Indonesia
- Investigators
- Antonius H. Pudjiadi, MD, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788589
- Sponsor's protocol ID
- 20030379
- Status last verified
- Jun 2022
- First submitted
- 13 Feb 2021
- Last updated
- 14 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sedation and Ventilator Weaning Protocol - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04788589
- Acronym / sponsor ID
- 20030379
- Conditions
- Mechanical Ventilation, Sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 9 Mar 2021 (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 research is a single-blinded, randomized controlled trial involving mechanically ventilated children in Pediatric Intensive Care Unit, Cipto Mangunkusumo Hospital, Indonesia. Subjects were divided into two groups: intervention vs control group. Primary and secondary outcomes will be measure pre, during, and post treatment.
Detailed description
As of today, there is no sedation and ventilator weaning protocol in our PICU. Decision for sedation and ventilator weaning were based on attending physicians clinical judgement, which greatly varies among individual. Previous study on the use of these protocols showed a favorable outcome. We aim to assess the safety and effectiveness of this protocol in our PICU.
Subjects were recruited consecutively and randomized into intervention and control group.
- Intervention group: sedation and ventilator weaning protocol
- Control group: no protocol
Primary outcomes:
- FLACC score
- COMFORT score
- Ventilator days
Secondary outcomes:
- Self extubation
- Reintubation
- PICU Length of stay
- Frequency of asynchrony
- NIRS value
- VIS score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation and Ventilator Weaning Protocol | Experimental | Other: Sedation and ventilator weaning protocolSedation: start midazolam 5-10 mins (max 3x). If MV 12 hrs-2d: Pain: morphine @2 hrs if needed (max 10mg/x). Sedation: midazolam @ 1-2 hrs if needed (max 10mg/x). If MV >2 d: morphine \& midazolam drip (max 10mg/hr). MV weaning checklist @morning. Pass if no incr of sedation dose due to agitation, NMBAs, incr in ICP. Fail: reassessed tomorrow. Pain and SBS scores assessed @morning until extubation. Stop all sedation and analgetic for sedation. Continue analgetics for pain. Subjects monitored for 4 hrs. Assess pain and WAT-1 score. Pass (GCS of E3, tolerate sedation interruption for > 4 hrs): MV weaning protocol. Fail (Persistent anxiety/agitation, incr pain score, incr RR > 5 mins, SpO2 <88% >5 mins, acute heart dysrhythmia, >=2 signs of ARDS): sedation resumed ½ dose, up titrated. MV weaning: CPAP 5/PS < 7. Pass: No failure criteria for 2 hrs. Fail (Incr RR > 5 mins, SpO2 <88% > 5 mins, acute decr in GCS/acute heart dysrhythmia, >=2 signs of ARDS): previous MV setting. |
| Control | No intervention | –1. Informed consent 2. Randomization into groups 3. Sedation and ventilator weaning according to attending physicians 4. Pain scores and SBS score is noted every 6 hours for the first 24 hours, and every day for the next 24 hours until extubation. 5. Attending physicians assessed that subject could be weaned: pain scores, SBS score, WAT-1 score 6. Extubation. Researcher did not take part in the judgement of extubation. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patient who need mechanical ventilation for more than 12 hours
Key exclusion criteria (1 listed)
- PICU admission due to post cardiac and respiratory arrest
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 |
|---|---|---|
| Sedation and ventilator weaning protocolSubjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before. | Other | Sedation and Ventilator Weaning Protocol |
Primary outcome
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
Time frame: every 6 hours for the first 24 hours, once daily until extubation. This is the baseline. Once the patient was intubated, FLACC scoring of hour 0 will be assessed and noted.
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 6
Time frame: FLACC scoring of hour 6 will be measured 6 hours after hour 0 was measured. Hour 6 is measured from the time the subject was intubated.
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 12
Time frame: FLACC scoring of hour 12 will be measured 12 hours after hour 0 was measured. Hour 12 is measured from the time the subject was intubated.
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 18
Time frame: FLACC scoring of hour 18 will be measured 18 hours after hour 0 was measured. Hour 18 is measured from the time the subject was intubated.
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Face, Leg, Activity, Cry, Consolability (FLACC) score day 1 until extubation
Time frame: Scoring will be assessed every morning. If the subject was intubated at night, scoring for day 1 will be measured in the morning the day after tomorrow. Thereafter, the measurement will be taken every morning, 24 hour apart until the subject extubation.
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day
Time frame: This score will be taken when the subject was stopped from all sedative and analgetics, just before extubation. Monitoring of extubation will be conducted until 56 days after initial intubation.
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
COMFORT score hour 0
Time frame: This is the baseline. Once the patient was intubated, COMFORT scoring of hour 0 will be assessed and noted.
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
COMFORT score hour 6
Time frame: COMFORT scoring of hour 6 will be measured 6 hours after hour 0 was measured. Hour 6 is measured from the time the subject was intubated.
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
COMFORT score hour 12
Time frame: COMFORT scoring of hour 12 will be measured 12 hours after hour 0 was measured. Hour 12 is measured from the time the subject was intubated.
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
COMFORT score hour 18
Time frame: COMFORT scoring of hour 18 will be measured 18 hours after hour 0 was measured. Hour 18 is measured from the time the subject was intubated.
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
COMFORT score day 1 until extubation
Time frame: Scoring will be assessed every morning. If the subject was intubated at night, scoring for day 1 will be measured in the morning the day after tomorrow. Thereafter, the measurement will be taken every morning, 24 hour apart until the subject extubation.
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
COMFORT score extubation day
Time frame: This score will be taken when the subject was stopped from all sedative and analgetics, just before extubation. Monitoring of extubation will be conducted until 56 days after initial intubation.
Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated
Ventilator time
Time frame: From intubation to extubation which would not need reintubation within 48 hours of extubation, measurement of the time frame may be assessed up to 28 days measured from intubation time.
Time to extubation (days)
9 secondary outcomes
Reintubation frequency
Time frame: Frequency of subject who are extubated to be reintubated within 48 hours after extubation. Assessment will be noted up to 28 days measured from the first time intubation was performed.
Self extubation frequency
Time frame: Frequency of self extubation by the patient during one episode of intubation. Assessment will be noted up to 28 days measured from the first time intubation was performed.
PICU length of stay
Time frame: Length of stay in PICU from admission until patient's death or step-down to the pediatric ward. Assessment of PICU length of stay will be noted up to 56 days measured from the first day of PICU admission as day 1.
Near infrared spectroscopy minute 5
Time frame: The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-1
Time frame: The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-6
Time frame: The scoring will be noted during hour-6 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-12
Time frame: The scoring will be noted during hour-12 after sedatives/analgetic administration following intubation.
Inotropic intervention
Time frame: The inotropic intervention will be noted throughout PICU admission up to 14 days of mechanical ventilation days.
Vasoactive-Inotropic Score
Time frame: The VIS score will be measured once during PICU admission up to 14 days of mechanical ventilation days.. The highest value will be recorded and categorized into two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Antonius H. Pudjiadi, MD, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation and ventilator weaning protocol in people with Mechanical Ventilation and Sedation, run by Universitas Indonesia at 1 site in Indonesia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0 (time frame: every 6 hours for the first 24 hours, once daily until extubation. This is the baseline. Once the patient was intubated, FLACC scoring of hour 0 will be assessed and noted.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2022.