Back to resultsLISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin
Primary Purpose
Respiratory Distress Syndrome in Preterm Infants
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rigid catheter
Soft catheter
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome in Preterm Infants
Eligibility Criteria
Inclusion Criteria:
- Level III NICU consultants and residents will be eligible to participate in the study
Exclusion Criteria:
- There are no exclusion criteria for this study
Sites / Locations
- Poliambulanza Breacia
- Azienda Ospedaliera di Padova, University of Padova
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Less invasive surfactant administration (LISA) with a rigid catheter
Less invasive surfactant administration (LISA) with a soft catheter
Arm Description
Participants will simulate the procedure of surfactant administration by using a rigid catheter
Participants will simulate the procedure of surfactant administration by using a soft catheter
Outcomes
Primary Outcome Measures
Total time of device (catheter) positioning
The time of device positioning defined as the time elapsed from the positioning of the laryngoscope in the manikin mouth to the connection of the syringe for surfactant administration to the catheter
Secondary Outcome Measures
Success of device positioning at the first attempt
We will evaluate the success of the device (catheter) at the first attempt
Achievement of the correct depth of the catheter in the trachea
The correct depth of the catheter tip in the trachea will be evaluated by an external observer
Participant's opinion regarding the procedure
Participant's opinion regarding the feasibility or difficulty of the procedure will be evaluated by using a questionnaire with items (1 worse to 5 best outcome) to be evaluated by a Likert scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05388175
Brief Title
LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin
Official Title
Time of Device Positioning of LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin: A Crossover Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
June 5, 2022 (Actual)
Study Completion Date
June 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Padova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown. A difficult procedure may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device, which is likely to aggravate the invasiveness of the procedure and result in stressful consequences such as bradycardia, hypoxia, and hemodynamic changes.
Objectives: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction.
Detailed Description
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA with a rigid catheter vs. LISA with a soft catheter in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first attempt, the number of attempts to achieve the correct positioning of the device in the trachea, the achievement of the correct depth of the catheter in the trachea, and the participant's opinion on using the device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome in Preterm Infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
Statistician will be blinded of the treatment group
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Less invasive surfactant administration (LISA) with a rigid catheter
Arm Type
Experimental
Arm Description
Participants will simulate the procedure of surfactant administration by using a rigid catheter
Arm Title
Less invasive surfactant administration (LISA) with a soft catheter
Arm Type
Active Comparator
Arm Description
Participants will simulate the procedure of surfactant administration by using a soft catheter
Intervention Type
Device
Intervention Name(s)
Rigid catheter
Other Intervention Name(s)
Less invasive surfactant administration (LISA) with a rigid catheter
Intervention Description
Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration
Intervention Type
Device
Intervention Name(s)
Soft catheter
Other Intervention Name(s)
Less invasive surfactant administration (LISA) with a soft catheter
Intervention Description
Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration
Primary Outcome Measure Information:
Title
Total time of device (catheter) positioning
Description
The time of device positioning defined as the time elapsed from the positioning of the laryngoscope in the manikin mouth to the connection of the syringe for surfactant administration to the catheter
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Success of device positioning at the first attempt
Description
We will evaluate the success of the device (catheter) at the first attempt
Time Frame
1 minute
Title
Achievement of the correct depth of the catheter in the trachea
Description
The correct depth of the catheter tip in the trachea will be evaluated by an external observer
Time Frame
5 minutes
Title
Participant's opinion regarding the procedure
Description
Participant's opinion regarding the feasibility or difficulty of the procedure will be evaluated by using a questionnaire with items (1 worse to 5 best outcome) to be evaluated by a Likert scale
Time Frame
5 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Level III NICU consultants and residents will be eligible to participate in the study
Exclusion Criteria:
There are no exclusion criteria for this study
Facility Information:
Facility Name
Poliambulanza Breacia
City
Brescia
Country
Italy
Facility Name
Azienda Ospedaliera di Padova, University of Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be shared upon motivated request to the PI
IPD Sharing Access Criteria
Upon motivated request to the PI
Learn more about this trial
LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin
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