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Completed

NCT Number: NCT05482230

Application of Tracheal Intubation in Lateral Position in Thoracic Surgery

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jie Zhao

Hangzhou, Zhejiang, A0094, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intubation and bronchial blocker placement performed in lateral position

Procedure

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.

Primary outcomes

  1. The incidence of bronchial blocker malposition.

    Time frame: During surgery

    The incidence of bronchial blocker malposition in two groups S and L

Secondary outcomes

  1. The times of bronchial blocker reposition

    Time frame: During surgery

    The times of bronchial blocker reposition in lateral group and supine group

  2. 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)

  3. The pressure of ventilation

    Time frame: During surgery

    The pressure of ventilation during mask ventilation, two-lung ventilation (TLV) and one-lung ventilation(OLV)

  4. 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

  5. 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

  6. 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

  7. 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

  8. Hypoxemia

    Time frame: During surgery

    Hypoxemia was defined as a drop in oxygen saturation (SpO2) below 92%

  9. 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).

Sponsors and collaborators

Lead sponsor

xiangming fang

Other

Collaborators

  • Affiliated Hospital of Guangdong Medical University
  • Affiliated Hospital of Jiaxing University
  • Affiliated Hospital of Shaoxing University
  • Lishui Country People's Hospital
  • Red Cross Hospital, Hangzhou, China
  • The Central Hospital of Lishui City

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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