Application of Tracheal Intubation in Lateral Position in Thoracic Surgery

• Sponsor: xiangming fang (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05482230
• Collaborator: Red Cross Hospital, Hangzhou, China (Other), The Central Hospital of Lishui City (Other)
• Enrollment: 300
• Arms: 4
• Anticipated Duration (Months): 6.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Tracheal Intubation; Thoracic Surgery	Other: Changes in intubation position	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double-lumen tube or bronchial blocker in lateral positiondouble-lumen tube or bronchial blocker in lateral position
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Application of Visual Laryngoscope-guided Tracheal Intubation in Lateral Position in Thoracic Surgery:A Prospective, Multicenter, Large Sample, Randomized Controlled Study
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Feb 28, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: DLT in supine position The double-lumen bronchial group was inserted in supine position
Experimental: DLT in lateral position The double-lumen bronchial group was inserted in lateral position	Other: Changes in intubation position; The change of intubation mode is accomplished in lateral position
No Intervention: BB in supine position The bronchial blocker group was inserted in supine position
Experimental: BB in lateral position The bronchial blocker group was inserted in lateral position	Other: Changes in intubation position; The change of intubation mode is accomplished in lateral position

Outcome Measures

Primary Outcome Measures

1. Intubation and location time [During surgery]

   From the laryngoscope to the trachea tube main capsule into the target bronchus

2. Success rate of single intubation [During surgery]

   A DLT or BB was successfully inserted into the target bronchus

3. Intubation displacement [During surgery]

   Intubation displacement in different positions was recorded

Secondary Outcome Measures

1. Hemodynamic fluctuation [During surgery]

   Hemodynamic fluctuations were recorded under different positions of intubation

2. QS pulmonary shunt [During surgery]

   Intrapulmonary shunt in different positions was recorded

3. Cough score [Within 3 days after surgery]

   Cough score in different positions was recorded

4. Grading of glottis exposure [During surgery]

   Grading of glottis exposure in different positions was recorded

5. extremity and nerve injury [During surgery]

   extremity and nerve injury in different positions was recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients aged over than 18 years and less than 60 years

• The American Society of Anesthesiologists (ASA) score was grade Ⅰ to Ⅱ, 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• xiangming fang
• Red Cross Hospital, Hangzhou, China
• The Central Hospital of Lishui City

Investigators

• Principal Investigator: Xiangming Fang, Professor, First Affilated Hospital of Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: xiangming fang, Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor, First Affiliated Hospital of Zhejiang University
• ClinicalTrials.gov Identifier: NCT05482230
• Other Study ID Numbers: 2015299
• First Posted: Aug 1, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by xiangming fang, Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor, First Affiliated Hospital of Zhejiang University: Lateral Position; Double-lumen Tube; Bronchial occluder
• Additional relevant MeSH terms: Aneurysm, Dissecting

Study Results

No Results Posted as of Aug 1, 2022