Effectiveness of Detachment of the Breathing Circuit on the Rate of DLT Malposition After Postural Change

NCT06182371 | Completed

• 1 other identifier: MLv
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the incidence of double-lumen endobronchial tube displacement in patients undergoing thoracic surgery with a change in position, compared with double-lumen endobronchial tube malposition in chest surgery patients with a fixed breathing circuit. The study is to investigate: whether detaching the breathing circuit in patients undergoing thoracic surgery would reduce the rate of double-lumen endobronchial tube malposition, the incidence of postoperative pulmonary complications, and improve patient outcomes. Participants will be randomly divided into a disconnected breathing circuit group and a breathing circuit connected group and after entering the operating room, the intravenous access will be opened, and blood pressure, heart rate, electrocardiogram, oxygen saturation, arterial pressure, and end-expiratory carbon dioxide will be monitored. Anesthesia induction will be performed by an anesthesiologist, and then the double-lumen endobronchial tube will be inserted under laryngoscopic guidance. Will the catheter be delivered to the expected depth, the double-lumen endobronchial tube will be connected to the anesthesia machine for mechanical ventilation. Researchers will compare the malposition rate of the double-lumen endobronchial tube when the patient transitions from the supine to lateral decubitus position, the effect of single-lung ventilation, oxygen saturation at 5 and 10 minutes after single-lung ventilation, and postoperative recovery time.

Conditions

Patient Positioning; Intratracheal Intubation

Keywords

Double-Lumen Endobronchial Tube; Positional changes; Disengage; Breathing circuit; Malposition

Outcome Measures

Primary Outcomes (1)

• Malposition rate of a double-lumen endobronchial tube

  Double-lumen endobronchial tube malposition is more than 5 mm away from the optimal position of the catheter. Severe malposition is the inability to see the upper left or lower left bronchial opening in the left common bronchi: the right upper lobe bronchial opening cannot be seen clearly in the right common bronchi; or bronchial cuffs more than 50% in the trachea.

  Immediately after a change in body position

Secondary Outcomes (3)

• Effects of lung collapse

  5 and 10 minutes after the pleura opens

• Blood oxygen saturation

  1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation

• PACU length of stay

  The time from the transfer to the PACU to the transfer out to ward, an average of an hour

Other Outcomes (3)

• Partial pressure of carbon dioxide at the end of expiration

  1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation

• Blood pressure

  1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation

• Heart rate

  1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation

Study Arms (2)

Disengagement of the breathing circuit

EXPERIMENTAL

When the patient's position is changed from the supine position to the lateral decubitus position, the anesthesiologist disengages the breathing circuit.

Behavioral: Disengage the breathing circuit

Connect the breathing circuit

NO INTERVENTION

When the patient's position is changed from the supine position to the lateral decubitus position, the anesthesiologist maintains the normal connection of the breathing line.

Interventions

Disengage the breathing circuit BEHAVIORAL

Disengage the breathing circuit when the position of the patient undergoing thoracic surgery changes

Disengagement of the breathing circuit

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II elective surgery for patients
• Patients undergoing thoracic surgery requiring a left-sided double-lumen endobronchial tube;
• Sign the informed consent form for this clinical study.

You may not qualify if:

• Mouth opening \<3cm;
• History of previous difficult intubation;
• Patients with diseases of the upper respiratory tract and main bronchi;
• Cardiac insufficiency;
• People with liver dysfunction;
• Renal insufficiency;
• Previous stroke;
• Patients with severe obstructive ventilation dysfunction;
• Bronchial asthma or airway hyperresponsiveness;
• Patients who have participated in other clinical studies in the past 3 months.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, S, 250021, China

Location

Related Publications (1)

• Lv S, Lv M, Du W, Zou Z, Zheng K, Qu J, Han X, Mao J. Does ventilator circuit disconnection during lateral positioning reduces the rate of double-lumen endotracheal tube displacement in thoracic surgery? a study protocol for a randomized controlled trial. Trials. 2026 Feb 28. doi: 10.1186/s13063-026-09567-w. Online ahead of print.

  PMID: 41761244 DERIVED

Study Officials

• Jin Bao Mao, Ph.D.

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: As this research uses a behavioral intervention, it will conceal the grouping from the subjects. Random numbers will be placed in opaque envelopes by independent persons not involved in this experiment to achieve allocation concealment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Model Details: Intervention: After the insertion of a DLT under general anesthesia, the anesthesiologist disengaged the breathing circuit when the patient transitioned from the supine to the lateral position.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 26, 2023
• Study Start: May 16, 2025
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-01

Locations

CN (1)