- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05482230
Application of Tracheal Intubation in Lateral Position in Thoracic Surgery
Lung Isolation With a Bronchial Blocker Placed in the Lateral Position for Patients Undergoing Thoracic Surgery: a Multicenter, Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, A0094
- Jie Zhao
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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.
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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
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During surgery
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The duration of intubation
Time Frame: During surgery
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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)
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During surgery
|
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The pressure of ventilation
Time Frame: During surgery
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The pressure of ventilation during mask ventilation, two-lung ventilation (TLV) and one-lung ventilation(OLV)
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During surgery
|
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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.
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Intubation-related complications, including airway injury, dental injury, sore throat, and hoarseness
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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.
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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.
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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
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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.
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Lung collapse grade
Time Frame: During surgery
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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
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During surgery
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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.
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Perioperative vital signs, including mean arterial pressure (MAP), heart rate (HR), and SpO2
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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.
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Hypoxemia
Time Frame: During surgery
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Hypoxemia was defined as a drop in oxygen saturation (SpO2) below 92%
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During surgery
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The satisfaction scores
Time Frame: Perioperative period
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The satisfaction scores of patients, nurses and surgeons.
Satisfaction scores were used a 0-10 scale (10 = very satisfied).
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Perioperative period
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Xiangming Fang, Professor, First Affilated Hospital of Zhejiang University
Publications and helpful links
General Publications
- 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. doi: 10.4103/0366-6999.189069.
- Almeida C, Freitas MJ, Brandao D, Assuncao JP. [Use of bronchial blocker in emergent thoracotomy in presence of upper airway hemorrhage, and cervical spine fracture: a difficult decision]. Braz J Anesthesiol. 2018 Jul-Aug;68(4):408-411. doi: 10.1016/j.bjan.2017.09.004. Epub 2018 Jan 17.
- 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. doi: 10.1016/1053-0770(92)90056-d.
- 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. doi: 10.1213/01.ane.0000100741.46539.6b.
- 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.
- 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):896-898. doi: 10.1213/01.ANE.0000048839.12552.50.
- 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. doi: 10.1093/bja/aei226. Epub 2005 Sep 2.
- 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.
- 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: 10.1097/MD.0000000000009461.
- 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. No abstract available.
- 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-2016-014112.
- 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. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015299
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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