Trial Outcomes & Findings for Inhaled Hypertonic Saline Use in the Emergency Department to Treat Acute Viral Bronchiolitis (NCT NCT02045238)
NCT ID: NCT02045238
Last Updated: 2015-01-12
Results Overview
Patients staying longer than 24h are considered to be admitted to ward.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
24 hours
Results posted on
2015-01-12
Participant Flow
Participant milestones
| Measure |
Normal Saline
Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat\>94% AND respiratory rate \<60 AND RDAI score \<4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate
|
Hypertonic Saline
Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat\>94% AND respiratory rate \<60 AND RDAI score \<4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
9
|
14
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhaled Hypertonic Saline Use in the Emergency Department to Treat Acute Viral Bronchiolitis
Baseline characteristics by cohort
| Measure |
Normal Saline
n=16 Participants
Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat\>94% AND respiratory rate \<60 AND RDAI score \<4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate
|
Hypertonic Saline
n=15 Participants
Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat\>94% AND respiratory rate \<60 AND RDAI score \<4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Number of participants analyzed was too small to obtain statistic significance
Patients staying longer than 24h are considered to be admitted to ward.
Outcome measures
| Measure |
Normal Saline
n=9 Participants
Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat\>94% AND respiratory rate \<60 AND RDAI score \<4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate
|
Hypertonic Saline
n=14 Participants
Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat\>94% AND respiratory rate \<60 AND RDAI score \<4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate
|
|---|---|---|
|
Rate of Admission
|
3 participants
|
6 participants
|
PRIMARY outcome
Timeframe: 24 hoursDischarge criteria are: Room air saturation \>94% AND respiratory rate \< 60 AND Respiratory Distress Assessment Instrument (RDAI) score inferior than 4, maintained over a 4 hour period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursActual time to discharge was considered of secondary importance as it can be influenced by individual considerations like patient age or time of the day.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 daysThe mere attendance to the Emergency Department will not be isolately considered, as it may be due to a scheduled reevaluation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursPopulation: Number of patients too small to achieve statistical significance
Any adverse effects directly attributable to treatment shall be noted. Mere lack of improve or worsening of symptoms attributable to the disease clinical course will not be considered as adverse effects.
Outcome measures
| Measure |
Normal Saline
n=9 Participants
Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat\>94% AND respiratory rate \<60 AND RDAI score \<4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate
|
Hypertonic Saline
n=14 Participants
Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat\>94% AND respiratory rate \<60 AND RDAI score \<4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.
Chest X-Ray
Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate
|
|---|---|---|
|
Incidence of Adverse Effects
|
0 participants
|
0 participants
|
Adverse Events
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypertonic Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mateus Deckers Leme
Hospital Universitario - Sao Paulo University
Phone: X551130919200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place