Clinical trial NCT07014345: Double-Lumen Tube Intubation in the Lateral Position Versus the Supine Position on First-Attempt Success Rate
Official title: Double-Lumen Tube Intubation in the Lateral Position Versus the Supine Position on First-Attempt Success Rate Among Patients Undergoing Thoracic Surgery: A Prospective, Randomized, Controlled, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Double Lumen Tube Intubation
Keywords: Double-lumen tube
lateral position intubation
first-attempt success rate
thoracic surgery
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Red Cross Hospital, Hangzhou, China
name: The First Affiliated Hospital of Guangzhou Medical University
name: Central People's Hospital of Zhanjiang
name: The Central Hospital of Lishui City
First posted: 2025-06-11
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to find out the first success rate of double lumen intubation in the lateral position in thoracic surgery, it will also find out the safety of double lumen tube intubation in the lateral position. The trial aims to answer the following key questions

Does intubation in lateral position improve the first-time success rate of double-lumen intubation compared with in the supine position? What medical problems can participants experience during double lumen tube intubation in the lateral position? The researchers will compare double lumen intubation in the lateral position vs supine position to see if the position is effective in the success rate of double lumen intubation.

Participants will

Use the supine or lateral position during intubation


Eligibility criteria: Inclusion Criteria:

* need for DLT intubation with elective unilateral thoracoscopic surgery
* age 18-65 years
* American Society of Anesthesiologists (ASA) grade of I or II
* no serious cardiopulmonary disease

Exclusion Criteria:

* aged \<18 years or \>65 years
* body mass index \>30 kg/m2
* cognitive dysfunction and inability to assume the required body position
* previous cervical vertebrae and expected difficult airway (e.g., Mallampati airway grade of III, IV, or higher, maximum mouth opening \<3 finger widths, nail-chin distance \<6 cm)
* admission to the intensive care unit after surgery and without follow-up

Primary outcomes:
measure: Successful First-Pass Intubation
timeFrame: Periprocedural
Secondary outcomes:
measure: No. of intubation attempts
timeFrame: Periprocedural
measure: Intubation time
timeFrame: Periprocedural
measure: Interval before surgery
timeFrame: Periprocedural
measure: p-Peak
timeFrame: Periprocedural
measure: Flexible bronchoscope usage
timeFrame: Periprocedural
measure: the incidence of DLT malposition
timeFrame: Periprocedural
measure: early intubation-related complications
timeFrame: Periprocedural
measure: postoperative complications
timeFrame: Periprocedural
measure: satisfaction scores.
timeFrame: Periprocedural
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: China
state: Zhejiang
Study officials:
References:
citation: Kim H, Seol T, Han SH, Kim H, Hwang JY. A bench study on the prevention of lung-to-lung aspiration with double-lumen endobronchial tubes and bronchial blockers. Sci Rep. 2024 Jan 2;14(1):187. doi: 10.1038/s41598-023-50792-z.
citation: Campos JH. Lung isolation techniques for patients with difficult airway. Curr Opin Anaesthesiol. 2010 Feb;23(1):12-7. doi: 10.1097/ACO.0b013e328331e8a7.
citation: Brodsky JB. Lung separation and the difficult airway. Br J Anaesth. 2009 Dec;103 Suppl 1:i66-75. doi: 10.1093/bja/aep262.
citation: Yang M, Kim JA, Ahn HJ, Choi JW, Kim DK, Cho EA. Double-lumen tube tracheal intubation using a rigid video-stylet: a randomized controlled comparison with the Macintosh laryngoscope. Br J Anaesth. 2013 Dec;111(6):990-5. doi: 10.1093/bja/aet281. Epub 2013 Aug 23.
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