Using ultrasound to determine the position of the gap between ribs during surgery

ISRCTN ISRCTN10722758
DOI https://doi.org/10.1186/ISRCTN10722758
Secondary identifying numbers 2100043
Submission date
12/03/2019
Registration date
06/04/2019
Last edited
26/05/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Mrs Chenxi Li
Scientific

No.7
Weiwu Road
Jinshui District
Zhengzhou City
Henan Province
Zhengzhou
450000
China

ORCiD logoORCID ID 0000-0001-8107-8931
Phone 0371-65964376
Email l15713895229@163.com

Study information

Study designObservational
Primary study designObservational
Secondary study designN/A
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet
Scientific titleThe accuracy and efficiency of positioning of the intercostal space under ultrasound guidance compared with manual positioning: an observational study
Study objectivesCompared with manual positioning, the ultrasound-guided rib gap is more accurate and faster.
Ethics approval(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedLocating the intercostal space during surgery
InterventionThe 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 typeOther
Primary outcome measureThe 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 measuresTotal time of manual positioning and ultrasonic positioning of the intercostal space.
Overall study start date01/12/2018
Completion date01/10/2019

Eligibility

Participant type(s)Patient
Age groupAll
Lower age limit18 Years
SexBoth
Target number of participants70
Key inclusion criteria1. Undergoing thoracoscopic lung surgery
2. Aged 18 years or older
Key exclusion criteria1. Undergoing thoracoscopic single-hole operation
2. Subcutaneous emphysema
3. Rib fractures
Date of first enrolment01/06/2019
Date of final enrolment01/10/2019

Locations

Countries of recruitment

  • China

Study participating centre

Henan Provincial People's Hospital
450000
China

Sponsor information

Henan Provincial People's Hospital
Hospital/treatment centre

Jinshui District, Zhengzhou City, Henan Province, China
Zhengzhou
450000
China

Phone 15713895229
Email l15713895229@163.com
ROR logo "ROR" https://ror.org/03f72zw41

Funders

Funder type

Hospital/treatment centre

Henan Provincial People's Hospital

No information available

Results and Publications

Intention to publish date31/08/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 23/05/2020 26/05/2020 Yes No

Editorial Notes

26/05/2020: Publication reference added.
15/04/2019: The recruitment start date was changed from 01/12/2018 to 01/06/2019.
12/04/2019: Internal review.
05/04/2019: Trial's existence confirmed by the Henan Science and Technology Project.