Clinical trial NCT05482230: Application of Tracheal Intubation in Lateral Position in Thoracic Surgery
Official title: Lung Isolation With a Bronchial Blocker Placed in the Lateral Position for Patients Undergoing Thoracic Surgery: a Multicenter, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Tracheal Intubation
Thoracic Surgery
Keywords: Lateral Position
Bronchial occluder
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Red Cross Hospital, Hangzhou, China
name: The Central Hospital of Lishui City
name: Affiliated Hospital of Guangdong Medical University
name: Affiliated Hospital of Jiaxing University
name: Affiliated Hospital of Shaoxing University
name: Lishui Country People's Hospital
First posted: 2022-08-01
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intubation and bronchial blocker placement performed in lateral position.
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of bronchial blocker malposition.
timeFrame: During surgery
Secondary outcomes:
measure: The times of bronchial blocker reposition
timeFrame: During surgery
measure: The duration of intubation
timeFrame: During surgery
measure: The pressure of ventilation
timeFrame: During surgery
measure: Intubation-related complications
timeFrame: 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.
measure: Postural injuries
timeFrame: 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.
measure: Lung collapse grade
timeFrame: During surgery
measure: Perioperative vital signs
timeFrame: 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.
measure: Hypoxemia
timeFrame: During surgery
measure: The satisfaction scores
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Jie Zhao
state: Zhejiang
Study officials:
affiliation: First Affilated Hospital of Zhejiang University
name: Xiangming Fang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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