Using ultrasound to determine the position of the gap between ribs during surgery
| ISRCTN | ISRCTN10722758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10722758 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2100043 |
| Sponsor | Henan Provincial People's Hospital |
| Funder | Henan Provincial People's Hospital |
- 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
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
Contact information
Scientific
No.7
Weiwu Road
Jinshui District
Zhengzhou City
Henan Province
Zhengzhou
450000
China
 ORCID ID |
0000-0001-8107-8931 |
|---|---|
| Phone | 0371-65964376 |
| l15713895229@163.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational |
| Secondary study design | N/A |
| Study type | Participant information sheet |
| Scientific title | The accuracy and efficiency of positioning of the intercostal space under ultrasound guidance compared with manual positioning: an observational study |
| Study objectives | Compared 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) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Total time of manual positioning and ultrasonic positioning of the intercostal space. |
| Completion date | 01/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 70 |
| Key inclusion criteria | 1. Undergoing thoracoscopic lung surgery 2. Aged 18 years or older |
| Key exclusion criteria | 1. Undergoing thoracoscopic single-hole operation 2. Subcutaneous emphysema 3. Rib fractures |
| Date of first enrolment | 01/06/2019 |
| Date of final enrolment | 01/10/2019 |
Locations
Countries of recruitment
- China
Study participating centre
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
