Plain English Summary
Background and study aims
Incorrect intercostal space positioning can cause inconvenience to surgeons, increasing surgery time and even increasing risk. The accuracy of the surgeon's manual positioning depends on the doctor's rich clinical experience and is also influenced by factors such as the patient's gender and body mass index. Determining the intercostal gap by ultrasound guidance is more intuitive. The focus of this double-blind randomized study was to assess the temporal accuracy of ultrasound in the positioning of the intercostal space and compare it to manual positioning.
Who can participate?
Anesthesiologists and surgeons.
What does the study involve?
The temporal accuracy of ultrasound in the positioning of the intercostal space and compare it to manual positioning.
What are the possible benefits and risks of participating?
There are no benefits or risks of participating.
Where is the study run from?
Henan Provincial People's Hospital.
When is the study starting and how long is it expected to run for?
December 2018 to October 2019.
Who is funding the study?
Wei Zhang，who works at Henan Provincial People's Hospital.
Who is the main contact?
Chenxi Li
l15713895229@163.com
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Chenxi Li
ORCID ID
http://orcid.org/0000-0001-8107-8931
Contact details
No.7
Weiwu Road
Jinshui District
Zhengzhou City
Henan Province
Zhengzhou
450000
China
0371-65964376
l15713895229@163.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2100043
Study information
Scientific title
The accuracy and efficiency of positioning of the intercostal space under ultrasound guidance compared with manual positioning: an observational study
Acronym
Study hypothesis
Compared with manual positioning, the ultrasound-guided rib gap is more accurate and faster.
Ethics approval
Not provided at time of registration.
Study design
Observational
Primary study design
Observational
Secondary study design
N/A
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Locating the intercostal space during surgery
Intervention
The anesthesiologist and the surgeon participated in the experiment. The surgeon uses the technique to locate the intercostal space and the anesthesiologist uses ultrasound to locate the intercostal space and record the time. After the operation started, after the thoracoscope entered the chest cavity, it is judged whether the positioning of the rib gap was correct by direct vision. There is no follow-up.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The accuracy of manual positioning and ultrasonic positioning of the rib gap is measured using the number of people positioned correctly divided by the total number of people.
Secondary outcome measures
Total time of manual positioning and ultrasonic positioning of the intercostal space.
Overall trial start date
01/12/2018
Overall trial end date
01/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Undergoing thoracoscopic lung surgery
2. Aged 18 years or older
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
70
Participant exclusion criteria
1. Undergoing thoracoscopic single-hole operation
2. Subcutaneous emphysema
3. Rib fractures
Recruitment start date
01/06/2019
Recruitment end date
01/10/2019
Locations
Countries of recruitment
China
Trial participating centre
Henan Provincial People's Hospital
450000
China
Sponsor information
Organisation
Henan Provincial People's Hospital
Sponsor details
Jinshui District
Zhengzhou City
Henan Province
China
Zhengzhou
450000
China
15713895229
l15713895229@163.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Henan Provincial People's Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement: the datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/08/2020
Participant level data
Other
Basic results (scientific)
Publication list