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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05482230
Other study ID # 2015299
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date March 31, 2023

Study information

Verified date July 2022
Source First Affiliated Hospital of Zhejiang University
Contact Jie Zhao, Doctor
Phone 8615068829652
Email zhaojie567@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a pilot study of DLT or BB intubation using a visual laryngoscope in lateral position,To investigate the feasibility of DLT and BB intubation in lateral position,To compare the influence of four endotracheal intubation methods on intrapulmonary shunt,It provides safety guarantee for chest operation under spontaneous breathing anesthesia.


Description:

With the popularization of rapid rehabilitation medical treatment, the application of anesthesia techniques such as laryngeal mask anesthesia under spontaneous breathing and carbon dioxide artificial pneumothorax in thoracic surgery is gradually increasing,However, it is necessary to replace the double-lumen tracheal catheter in emergency situations such as massive bleeding or single-lung ventilation during surgery. At this time, it is particularly important to master the skills of lateral decubitus intubation, which can shorten the rescue time and is of great significance to thoracic anesthesia. Secondly, the movement of body position under anesthesia has an impact on hemodynamics and limb injury.In addition, the influence of anesthesia induction in different positions on patients' intrapulmonary shunt can also be considered.The above indicators, intubation time and success rate were observed,To analyze the feasibility and significance of lateral decubitus intubation in thoracic surgery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date March 31, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - patients aged over than 18 years and less than 60 years - The American Society of Anesthesiologists (ASA) score was grade ? to ?, and there was no serious cardiopulmonary disease - Undergoing unilateral thoracoscopic surgery Exclusion Criteria: - patients aged less than 18 years or over than 60 years - BMI is over than 30kg/m2 - patients have cognitive dysfunction and cannot coordinate with body position - History of cervical vertebrae and expected difficult airway (e.g. Mallampati airway grade 4 or above, mouth opening <3 fingers, nail-chin distance <6cm) - Patients were sent to ICU after operation and could not cooperate with follow-up

Study Design


Intervention

Other:
Changes in intubation position
The change of intubation mode is accomplished in lateral position

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
xiangming fang Red Cross Hospital, Hangzhou, China, The Central Hospital of Lishui City

References & Publications (11)

Birring SS, Brew J, Kilbourn A, Edwards V, Wilson R, Morice AH. Rococo study: a real-world evaluation of an over-the-counter medicine in acute cough (a multicentre, randomised, controlled study). BMJ Open. 2017 Jan 16;7(1):e014112. doi: 10.1136/bmjopen-20 — View Citation

Biswas BK, Agarwal B, Bhattacharyya P, Badhani UK, Bhattarai B. Intubating laryngeal mask for airway management in lateral decubitus state: comparative study of right and left lateral positions. Br J Anaesth. 2005 Nov;95(5):715-8. Epub 2005 Sep 2. — View Citation

Dimitriou V, Voyagis GS, Iatrou C, Brimacombe J. Flexible lightwand-guided intubation using the intubating laryngeal mask airway in the supine, right, and left lateral positions in healthy patients by experienced users. Anesth Analg. 2003 Mar;96(3):896-89 — View Citation

Goh SY, Thong SY, Chen Y, Kong AS. Efficacy of intubation performed by trainees on patients in the lateral position. Singapore Med J. 2016 Sep;57(9):503-6. doi: 10.11622/smedj.2015165. Epub 2015 Nov 13. — View Citation

Jin Y, Ying J, Zhang K, Fang X. Endotracheal intubation under video laryngoscopic guidance during upper gastrointestinal endoscopic surgery in the left lateral position: A randomized controlled trial. Medicine (Baltimore). 2017 Dec;96(52):e9461. doi: 10.1 — View Citation

Komatsu R, Nagata O, Sessler DI, Ozaki M. The intubating laryngeal mask airway facilitates tracheal intubation in the lateral position. Anesth Analg. 2004 Mar;98(3):858-61, table of contents. — View Citation

Lai HC, Wu ZF. Easier double-lumen tube placement using real-time video laryngoscopy and wireless video fiberoptic bronchoscopy. J Clin Anesth. 2019 Aug;55:132-133. doi: 10.1016/j.jclinane.2018.12.023. Epub 2019 Jan 15. — View Citation

Lewis JW Jr, Serwin JP, Gabriel FS, Bastanfar M, Jacobsen G. The utility of a double-lumen tube for one-lung ventilation in a variety of noncardiac thoracic surgical procedures. J Cardiothorac Vasc Anesth. 1992 Dec;6(6):705-10. — View Citation

Li H, Wang W, Lu YP, Wang Y, Chen LH, Lei LP, Fang XM. Evaluation of Endotracheal Intubation with a Flexible Fiberoptic Bronchoscope in Lateral Patient Positioning: A Prospective Randomized Controlled Trial. Chin Med J (Engl). 2016 Sep 5;129(17):2045-9. d — View Citation

Saini S, Bhanot A, Kamal K, Bansal T. An improvised head support to facilitate endotracheal intubation in the lateral position. Acta Anaesthesiol Taiwan. 2015 Sep;53(3):109-11. doi: 10.1016/j.aat.2015.04.001. Epub 2015 Apr 24. — View Citation

Takenaka I, Aoyama K, Iwagaki T, Kadoya T. Efficacy of the Airway Scope on tracheal intubation in the lateral position: comparison with the Macintosh laryngoscope. Eur J Anaesthesiol. 2011 Mar;28(3):164-8. doi: 10.1097/EJA.0b013e328340c368. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Intubation and location time From the laryngoscope to the trachea tube main capsule into the target bronchus During surgery
Primary Success rate of single intubation A DLT or BB was successfully inserted into the target bronchus During surgery
Primary Intubation displacement Intubation displacement in different positions was recorded During surgery
Secondary Hemodynamic fluctuation Hemodynamic fluctuations were recorded under different positions of intubation During surgery
Secondary QS pulmonary shunt Intrapulmonary shunt in different positions was recorded During surgery
Secondary Cough score Cough score in different positions was recorded Within 3 days after surgery
Secondary Grading of glottis exposure Grading of glottis exposure in different positions was recorded During surgery
Secondary extremity and nerve injury extremity and nerve injury in different positions was recorded During surgery
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