Trial · NCT00871624
Efficacy and Safety of Dexmedetomidine During Non-Invasive Positive Pressure Ventilation
NCT00871624, Phase 2, Completed, Tufts Medical Center; results first posted 2015-12-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Dexmedetomidine During Non-Invasive Positive Pressure Ventilation. Trials, record NCT00871624. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00871624
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Dexmedetomidine During Non-Invasive Positive Pressure Ventilation
- NCT number
- NCT00871624
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Tufts Medical Center
- Conditions
- Acute Respiratory Failure
- Interventions
- Dexmedetomidine, Placebo
- First posted
- 2009-03-30
- Last updated
- 2017-12-18
- Results first posted
- 2015-12-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tolerability of NIV as Assessed by an NIV Tolerance Score | Completed at time 0min, 30min, 60min, 3hr, 6hr, 12hr, and then every 12 hours after the start of NPPV therapy up to 72 hours | NIV tolerance (NIV intolerance score =1 out of 4) A score of 1 for a comfortable and relaxed patient tolerating NIV; a score of 2 for mild intolerance with some discomfort and occasionally grabbing at the NIV mask; a score of 3 for moderate intolerance and discomfort with the NIV mask most of the time but more frequent grabbing at the mask, sometimes pulling it off; and a score of 4 for severe NIV intolerance with agitation and the inability to leave the NIV mask in place. The outcome measure description of the time frame is reported as the average of the NIV tolerance scores reported at the various time frames (0min, 30min, 60 min, 3hr, 6hr, 12hr, and then every 12hr after the start of NIV therapy up to 72 hours) |
| Secondary | Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive | Completed at baseline and every 4 hours after the start of NPPV therapy for the duration of the study | Percentage of time spent at desired sedation goal |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tolerability of NIV as Assessed by an NIV Tolerance Score | Completed at time 0min, 30min, 60min, 3hr, 6hr, 12hr, and then every 12 hours after the start of NPPV therapy up to 72 hours | percentage of time spent tolerant to NIV | MEDIAN | |
| SECONDARY | Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive | Completed at baseline and every 4 hours after the start of NPPV therapy for the duration of the study | percentage of time | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tolerability of NIV as Assessed by an NIV Tolerance Score | Dexmedetomidine | 99 | Inter-Quartile Range 61 to 100 | percentage of time spent tolerant to NIV | |
| Tolerability of NIV as Assessed by an NIV Tolerance Score | Placebo | 67 | Inter-Quartile Range 40 to 100 | percentage of time spent tolerant to NIV | |
| Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive | Dexmedetomidine | 100 | 95% Confidence Interval 86 to 100 | percentage of time | |
| Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive | Placebo | 100 | 95% Confidence Interval 100 to 100 | percentage of time |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexmedetomidine | 18 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | Dexmedetomidine | 16 | |
| Overall Study | COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexmedetomidine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dexmedetomidine | 0 | 18 |
| Total, other adverse events | Placebo | 0 | 18 |
| Total, serious adverse events | Dexmedetomidine | 0 | 18 |
| Total, serious adverse events | Placebo | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dexmedetomidine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00871624
GET https://conductscience.org/api/trials/v1/NCT00871624/registered