Trial Outcomes & Findings for EpiFaith Syringe for Epidural Space Detection (NCT NCT03983109)

Results Overview

Defined as the catheter can be inserted into epidural space successfully, no cold perception in the blocked dermatomes after the injection of anesthetic by cold sensation test, and no occurrence of inadvertent dural puncture.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

30 minutes

Results posted on

2024-07-05

Participant Flow

Subjects will be randomized to one of the two groups (A group - EpiFaith syringe with air or S group - EpiFaith syringe with saline) at the ratio of 1:1. The randomization method will result in sealed, opaque envelopes containing the computer- generated, random assignment. Randomization will occur in blocks so that blocks of equal numbers of subjects will be used to avoid potential runs of assignments.

Participant milestones

Participant milestones
Measure	Detection by EpiFaith Syringe With Air Fill the EpiFaith Syringe with air for LOR detection	Detection by EpiFaith Syringe With Saline Fill the EpiFaith Syringe with saline for LOR detection
Overall Study STARTED	30	30
Overall Study COMPLETED	18	30
Overall Study NOT COMPLETED	12	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Detection by EpiFaith Syringe With Air Fill the EpiFaith Syringe with air for LOR detection	Detection by EpiFaith Syringe With Saline Fill the EpiFaith Syringe with saline for LOR detection
Overall Study Operational Hurdles Linked to Usage Methodologies	12	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Detection by EpiFaith Syringe With Air n=30 Participants Fill the EpiFaith Syringe with air for LOR detection	Detection by EpiFaith Syringe With Saline n=30 Participants Fill the EpiFaith Syringe with saline for LOR detection	Total n=60 Participants Total of all reporting groups
Age, Continuous	57.83 years STANDARD_DEVIATION 10.47 • n=30 Participants	61.13 years STANDARD_DEVIATION 12.24 • n=30 Participants	59.48 years STANDARD_DEVIATION 11.32 • n=60 Participants
Sex: Female, Male Female	19 Participants n=30 Participants	13 Participants n=30 Participants	32 Participants n=60 Participants
Sex: Female, Male Male	11 Participants n=30 Participants	17 Participants n=30 Participants	28 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	24.57 kg/m^2 STANDARD_DEVIATION 4.31 • n=30 Participants	23.82 kg/m^2 STANDARD_DEVIATION 3.6 • n=30 Participants	24.14 kg/m^2 STANDARD_DEVIATION 3.92 • n=60 Participants
ASA Physical Status Status 1	3 Participants n=30 Participants	3 Participants n=30 Participants	6 Participants n=60 Participants
ASA Physical Status Status 2	21 Participants n=30 Participants	21 Participants n=30 Participants	42 Participants n=60 Participants
ASA Physical Status Status 3	6 Participants n=30 Participants	6 Participants n=30 Participants	12 Participants n=60 Participants

PRIMARY outcome

Timeframe: 30 minutes

Defined as the catheter can be inserted into epidural space successfully, no cold perception in the blocked dermatomes after the injection of anesthetic by cold sensation test, and no occurrence of inadvertent dural puncture.

Outcome measures

Outcome measures
Measure	Detection by EpiFaith Syringe With Air n=18 Participants Fill the EpiFaith Syringe with air for LOR detection	Detection by EpiFaith Syringe With Saline n=30 Participants Fill the EpiFaith Syringe with saline for LOR detection
Success of Epidural Localization Success of epidural localization	18 Participants	30 Participants
Success of Epidural Localization Failure of epidural localization	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 minutes

Defined as the time of the successful localization from the first syringe attached to the Tuohy needle to the occurrence of LOR signal.

Outcome measures

Outcome measures
Measure	Detection by EpiFaith Syringe With Air n=18 Participants Fill the EpiFaith Syringe with air for LOR detection	Detection by EpiFaith Syringe With Saline n=30 Participants Fill the EpiFaith Syringe with saline for LOR detection
The Time to Identify the Epidural Space	231 secs Standard Deviation 273	130 secs Standard Deviation 169

SECONDARY outcome

Timeframe: 30 minutes

Defined as the time from the puncture of skin to the successful insertion of the epidural catheter.

Outcome measures

Outcome measures
Measure	Detection by EpiFaith Syringe With Air n=18 Participants Fill the EpiFaith Syringe with air for LOR detection	Detection by EpiFaith Syringe With Saline n=30 Participants Fill the EpiFaith Syringe with saline for LOR detection
Duration of the Epidural Space Localization Procedure	309 secs Standard Deviation 276	194 secs Standard Deviation 182

SECONDARY outcome

Timeframe: 30 minutes

Defined as the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test.

Outcome measures

Outcome measures
Measure	Detection by EpiFaith Syringe With Air n=18 Participants Fill the EpiFaith Syringe with air for LOR detection	Detection by EpiFaith Syringe With Saline n=30 Participants Fill the EpiFaith Syringe with saline for LOR detection
Number of Attempts	2 attempts Interval 1.0 to 4.0	1 attempts Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 30 minutes

Defined as the insertion distance of the needle after locating the epidural space.

Outcome measures

Outcome measures
Measure	Detection by EpiFaith Syringe With Air n=18 Participants Fill the EpiFaith Syringe with air for LOR detection	Detection by EpiFaith Syringe With Saline n=30 Participants Fill the EpiFaith Syringe with saline for LOR detection
The Distance From the Skin to the Epidural Space	63.3 mm Standard Deviation 10.4	65.1 mm Standard Deviation 9.2

SECONDARY outcome

Timeframe: 30 minutes

Number of change insertion segment during the epidural localization procedure.

Outcome measures

Outcome measures
Measure	Detection by EpiFaith Syringe With Air n=18 Participants Fill the EpiFaith Syringe with air for LOR detection	Detection by EpiFaith Syringe With Saline n=30 Participants Fill the EpiFaith Syringe with saline for LOR detection
Number of Change Insertion Segment	0 segments Interval 0.0 to 1.0	0 segments Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 30 minutes

the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test

Outcome measures

Outcome measures
Measure	Detection by EpiFaith Syringe With Air n=18 Participants Fill the EpiFaith Syringe with air for LOR detection	Detection by EpiFaith Syringe With Saline n=30 Participants Fill the EpiFaith Syringe with saline for LOR detection
Number of the Occurrence of False Positive	0 occurrences Interval 0.0 to 2.0	0 occurrences Interval 0.0 to 1.0

Adverse Events

Detection by EpiFaith Syringe With Air

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Detection by EpiFaith Syringe With 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

LI YU LIN

Flat Medical Co., Ltd

Phone: +886 25672959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place