Application of Tracheal Intubation in Lateral Position in Thoracic Surgery

May 13, 2025 updated by: xiangming fang

Lung Isolation With a Bronchial Blocker Placed in the Lateral Position for Patients Undergoing Thoracic Surgery: a Multicenter, Randomized Clinical Trial

This study investigated the incidence of bronchial blocker malposition in the lateral versus supine position and evaluated the effectiveness of lateral placement.

Study Overview

Detailed Description

Routine thoracic surgery anesthesia requires that endotracheal intubation be performed with the patient in the supine position; the patient subsequently needs to be placed in a lateral position through the cooperation of the anesthetist, theatre nurse, and surgeon. Achieving this change in position is time-consuming and likely to result in adverse events, such as loss of the anesthetic airway and arteriovenous catheter, hemodynamic fluctuations, and malposition of the BB which adversely affect anesthesia management and postoperative recovery. For patients with hypertensive heart disease, the risk of cardiovascular and cerebrovascular accidents increases during the perioperative period .

Therefore, we conducted a prospective, randomized, controlled, multi-center study to evaluate the ease, efficacy, and safety of video laryngoscopy-guided intubation and bronchial blocker placement performed in lateral position.

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, A0094
        • Jie Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

The inclusion criteria :

  • 80 Years<age ≥18 years;
  • American Society of Anesthesiologists (ASA) physical status I-III;
  • Undergo thoracic surgery requiring one-lung ventilation.

The exclusion criteria were:

  • Risk of difficult intubation based on preoperative assessment (maximum mouth opening <3 cm, body mass index >30 kg/m2, limited neck movement, Mallampati grade IV, or main airway stenosis);
  • Right upper bronchus originating at or above the tracheal carina;
  • Plan to undergo bronchial sleeve resection, right upper lobectomy, or non-intubated thoracic surgery;
  • Evidence or symptoms of acute lung or airway infection;
  • History of thoracic surgery;
  • Prior thoracic radiotherapy or chemotherapy;
  • Preoperative upper extremity pain;
  • Severe mental illness or difficulty with communication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intubation and bronchial blocker placement performed in lateral position
In the lateral position group, patients were positioned laterally (as required for surgery) before anesthesia induction. After anesthesia induction, both endotracheal intubation and bronchial blocker placement were performed while the patient remained in the lateral position.
In the lateral position group, patients were positioned laterally (as required for surgery) before anesthesia induction. After anesthesia induction, both endotracheal intubation and bronchial blocker placement were performed while the patient remained in the lateral position.
No Intervention: Intubation and bronchial blocker placement performed in supine position
Intubation and the placement of a bronchial blocker are typically carried out with the patient in the supine position, which is a standard procedure in thoracic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of bronchial blocker malposition.
Time Frame: During surgery
The incidence of bronchial blocker malposition in two groups S and L
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The times of bronchial blocker reposition
Time Frame: During surgery
The times of bronchial blocker reposition in lateral group and supine group
During surgery
The duration of intubation
Time Frame: During surgery
The duration of intubation, including the time for single-lumen tube intubation, the time for bronchial blocker placement, and the total intubation time (single-lumen tube intubation plus bronchial blocker placement)
During surgery
The pressure of ventilation
Time Frame: During surgery
The pressure of ventilation during mask ventilation, two-lung ventilation (TLV) and one-lung ventilation(OLV)
During surgery
Intubation-related complications
Time Frame: During surgery, after the patient regained full consciousness and before discharge from the post-anesthesia care unit, on the day after surgery, and 2 weeks postoperatively.
Intubation-related complications, including airway injury, dental injury, sore throat, and hoarseness
During surgery, after the patient regained full consciousness and before discharge from the post-anesthesia care unit, on the day after surgery, and 2 weeks postoperatively.
Postural injuries
Time Frame: These complications were assessed at three time points: after the patient regained full consciousness and before discharge from the post-anesthesia care unit, on the day after surgery, and 2 weeks postoperatively.
Postural injuries were defined as new-onset injuries not present before surgery but occurring within the first 2 weeks postoperatively, including neuropathies, vasculopathies, and musculoskeletal injuries
These complications were assessed at three time points: after the patient regained full consciousness and before discharge from the post-anesthesia care unit, on the day after surgery, and 2 weeks postoperatively.
Lung collapse grade
Time Frame: During surgery
When the chest wall was opened, the lung collapse was graded as follows: fully collapsed lung, non-collapsed lung with no visible ventilation, or fully ventilated lung
During surgery
Perioperative vital signs
Time Frame: Immediately after arrival at operating room; Before single lumen tube intubation; After single lumen tube intubation ; One-lung ventilation; Before single lumen tube extubating; 5 minutes after single lumen tube extubating.
Perioperative vital signs, including mean arterial pressure (MAP), heart rate (HR), and SpO2
Immediately after arrival at operating room; Before single lumen tube intubation; After single lumen tube intubation ; One-lung ventilation; Before single lumen tube extubating; 5 minutes after single lumen tube extubating.
Hypoxemia
Time Frame: During surgery
Hypoxemia was defined as a drop in oxygen saturation (SpO2) below 92%
During surgery
The satisfaction scores
Time Frame: Perioperative period
The satisfaction scores of patients, nurses and surgeons. Satisfaction scores were used a 0-10 scale (10 = very satisfied).
Perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Actual)

May 13, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The patient's relevant vital signs and intubation parameters, etc

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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