| Protocol ID | NCT01413308 |
| Registration Date | 2011-08-10 |
| Status | Unknown Status |
| Sponsor | Rambam Health Care Campus |
| Country | – |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | – |
| Scope | – |
| First Patient In | 2011-09-01 |
| Last Patient Out | 2012-09-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 10 Years - |
NCT01413308
Long-term Effects on Pulmonary Function in Post- Fontan Operation
| Field |
CLAUDE
claude-sonnet-4-20250514 4803ms / 10375 tok |
GLM
glm-5.1 8331ms / 9058 tok |
OPENAI
gpt-4o Thinking: o3 2913ms / 8903 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | cardiac | cardiac | cardiac | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other |
other
hospital
shaky reasoning✓ Unanimous
Initial: hospital
|
other
other → hospital → other
shaky reasoning✓ Unanimous
Initial: other
Requery: hospital — The pulmonary function tests, including methacholine challenge, are performed at the Pediatric Pulmonary Unit, Meyer Children's Hospital, indicating hospital-based delivery.
Thinking: other — Pulmonary function tests are conducted in a hospital-based outpatient clinic (Pediatric Pulmonary Unit) without requiring inpatient admission.
|
OK |
| feasibility | N/A | N/A | N/A | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | no |
yes
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial measures pulmonary function, lung capacities, and oxygen saturation, which are physiologic metrics and symptom severity outcomes covered by symptom/QoL categories.
|
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial focuses on long-term pulmonary function, which relates to symptoms and physiological outcomes post-surgery, not other outcomes like caregiver perspectives or goal-concordant care.
Thinking: yes — The study’s outcomes are objective pulmonary function measurements, which are physiologic tests not falling under symptom relief, quality-of-life, dignity, or cost categories.
|
– |
| pharmacologic_sub | N/A | N/A | N/A | OK |