Trial · NCT02250820
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sedation Quality | 60 minutes | The primary outcome variable will be the sedation quality for the first 60 minutes after sedation drug is administered. It will be assessed if child is sedated within 30 minutes of administration of sedative drug, and if sedation is maintained for at least 30 minutes to allow a detailed transthoracic echocardiographic study. Sedation is defined as achieving Ramsay sedation level \>3. |
| Secondary | Time to sedation | Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes | Time from first dose of sedative medication to sedation. Sedation is defined as achieving Ramsay sedation level \>3. |
| Secondary | Delirium prior to sedation | Participants will be followed for the time it takes to reach a sedated state, an expected average of 30 minutes | The incidence of delirium prior to achieving sedation. |
| Secondary | Duration of sedation level >3 | Participants will be followed for the duration of the procedure, an expected average of 1 hour | |
| Secondary | Sonographer Pauses | Participants will be followed for the duration of the procedure, an expected average of 1 hour | The number of sonographer pauses over 2 minutes due to patient movement or medical intervention will be counted. |
| Secondary | Need for rescue nasal Dexmedetomidine | Participants will be followed for the duration of the procedure, an expected average of 1 hour | The incidence of need for rescue nasal dexmedetomidine, due to patient arousal or movement prior to completion of TTE. |
| Secondary | Incidence-severity of respiratory complications | Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours | We will document the incidence and severity of respiratory complications (including supplemental oxygen). |
| Secondary | Vital sign deviations of more than 30% from baseline | Participants will be followed for the duration of their outpatient hospital stay, an expected average of 2 hours | We will document the incidence of blood pressure or heart rate deviations of more than 30% from baseline. Baseline will be measured prior to sedative administration. |
| Secondary | Post anesthesia drowsiness or agitation | Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour | We will document the incidence-severity of post anesthesia drowsiness or agitation. |
| Secondary | Duration of Post Anesthesia Care Unit (PACU) Phase | Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour | We will document the duration of stay in Post Anesthesia Care Unit (PACU) phase in minutes. |
| Secondary | Time to oral fluid intake | Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour | We will document the time (in minutes) to oral fluid intake during the PACU phase |
| Secondary | Time to discharge | Participants will be followed for the duration of their post procedure stay, an expected average of 1 hour | We will document the time it takes a patient to be discharged from the hospital after the completion of the TTE. |
| Secondary | Satisfaction of the Parents | up to 3 days | The satisfaction of the sedation technique will be completed by the parents by asking a series of questions during a follow-up phone call the next business day after the TTE. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT02250820/registered