Trial Outcomes & Findings for A Trial on Ultrasound-assisted Spinal Anaesthesia (NCT NCT01699373)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

170 participants

Primary outcome timeframe

During procedure

Results posted on

2013-04-09

Participant Flow

April 2011-April 2012 Changi General Hospital

Participant milestones

Participant milestones
Measure	Ultrasound-assisted Pre-procedural ultrasound scan performed	Manual Palpation
Overall Study STARTED	85	85
Overall Study COMPLETED	85	85
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial on Ultrasound-assisted Spinal Anaesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasound-assisted n=85 Participants Pre-procedural ultrasound scan performed	Manual Palpation n=85 Participants	Total n=170 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants	85 Participants n=7 Participants	170 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	61.1 years STANDARD_DEVIATION 13.3 • n=5 Participants	63.7 years STANDARD_DEVIATION 12.6 • n=7 Participants	62.4 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	45 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	40 Participants n=7 Participants	95 Participants n=5 Participants
Region of Enrollment Singapore	85 participants n=5 Participants	85 participants n=7 Participants	170 participants n=5 Participants

PRIMARY outcome

Timeframe: During procedure

Outcome measures

Outcome measures
Measure	Ultrasound-assisted n=85 Participants Pre-procedural ultrasound scan performed	Manual Palpation n=85 Participants
Success Rate of First-attempt of Spinal Anaesthesia	54 participants	44 participants

SECONDARY outcome

Timeframe: During procedure

Outcome measures

Outcome data not reported

Adverse Events

Ultrasound-assisted

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Manual Palpation

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 Lim Yean Chin

Changi General Hospital

Phone: +65 68503831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place