Trial · NCT00945529
The Effects of Inhaled Nitric Oxide After Fontan Operation
NCT00945529, Phase 2, Phase 3, Completed, Ellen Spurrier; results first posted 2023-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of Inhaled Nitric Oxide After Fontan Operation. Trials, record NCT00945529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00945529
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Inhaled Nitric Oxide After Fontan Operation
- NCT number
- NCT00945529
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 21 participants, actual
- Lead sponsor
- Ellen Spurrier
- Conditions
- Congenital Heart Defect
- Interventions
- inhaled nitric oxide (iNO)
- First posted
- 2009-07-24
- Last updated
- 2023-05-19
- Results first posted
- 2023-05-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Hospital Stay Following Fontan | until hospital discharge | |
| Secondary | Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage | 2 weeks | Percent of patients with significant pleural fluid collections that required thoracostomy drainage |
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 | Length of Hospital Stay Following Fontan | until hospital discharge | days | MEAN | |
| SECONDARY | Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage | 2 weeks | percentage | NUMBER |
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 |
|---|---|---|---|---|---|
| Length of Hospital Stay Following Fontan | No Intervention/ Historical Control Group | 11.2 | Full Range 4 to 60 | days | |
| Length of Hospital Stay Following Fontan | Intervention | 11 | Full Range 4.5 to 31 | days | |
| Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage | No Intervention/ Historical Control Group | 43.5 | percentage | ||
| Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage | Intervention | 33.4 | percentage |
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 | No Intervention/ Historical Control Group | 23 | |
| Overall Study | STARTED | Intervention | 21 | |
| Overall Study | COMPLETED | No Intervention/ Historical Control Group | 23 | |
| Overall Study | COMPLETED | Intervention | 21 | |
| Overall Study | NOT COMPLETED | No Intervention/ Historical Control Group | 0 | |
| Overall Study | NOT COMPLETED | Intervention | 0 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pleural effusion requiring drainage | Respiratory, thoracic and mediastinal disorders | No Intervention/ Historical Control Group | 7 | 23 | 7 |
| other | Pleural effusion requiring drainage | Respiratory, thoracic and mediastinal disorders | Intervention | 6 | 21 | 6 |
| serious | prolonged hospital stay due to infection | Infections and infestations | No Intervention/ Historical Control Group | 5 | 23 | 5 |
| serious | prolonged hospital stay due to infection | Infections and infestations | Intervention | 2 | 21 | 2 |
| serious | Prolonged hospital stay due to feeding issue | Metabolism and nutrition disorders | No Intervention/ Historical Control Group | 0 | 23 | 0 |
| serious | Prolonged hospital stay due to feeding issue | Metabolism and nutrition disorders | Intervention | 1 | 21 | 1 |
| serious | Prolonged hospital stay due to atelectasis | Respiratory, thoracic and mediastinal disorders | No Intervention/ Historical Control Group | 0 | 23 | 0 |
| serious | Prolonged hospital stay due to atelectasis | Respiratory, thoracic and mediastinal disorders | Intervention | 1 | 21 | 1 |
| serious | Prolonged hospital stay due to pleural effusion | Respiratory, thoracic and mediastinal disorders | No Intervention/ Historical Control Group | 4 | 23 | 4 |
| serious | Prolonged hospital stay due to pleural effusion | Respiratory, thoracic and mediastinal disorders | Intervention | 1 | 21 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | No Intervention/ Historical Control Group | ||
| Total, all-cause mortality | Intervention | ||
| Total, other adverse events | No Intervention/ Historical Control Group | 7 | 23 |
| Total, other adverse events | Intervention | 6 | 21 |
| Total, serious adverse events | No Intervention/ Historical Control Group | 8 | 23 |
| Total, serious adverse events | Intervention | 5 | 21 |
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 |
|---|
| Intervention vs No Intervention/ Historical Control Group: 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/NCT00945529
GET https://conductscience.org/api/trials/v1/NCT00945529/registered