Condition category
Surgery
Date applied
12/03/2019
Date assigned
06/04/2019
Last edited
15/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

N/A

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

Publication citations

Additional files

Editorial Notes

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.