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

NCT ID: NCT06182371

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-01-31

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

Intratracheal Intubation; Patient Positioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Disengagement of the breathing circuit

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

Group Type: EXPERIMENTAL

Disengage the breathing circuit

Intervention Type: BEHAVIORAL

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

Connect the breathing circuit

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Disengage the breathing circuit

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Meng Lv

Deputy Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Bao Mao, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Hospital

Central Contacts

Meng Lv, Ph.D.

Role: CONTACT

qylvmeng@163.com

15169105373

Other Identifiers

MLv

Identifier Type: -

Identifier Source: org_study_id