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

Effectiveness of Detachment of the Breathing Circuit on the Rate of the Double-lumen Endotracheal Tube Malposition After the Change of Position in Patients Undergoing Thoracic Surgery: a Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06182371
Enrollment
256
Registered
2023-12-26
Start date
2025-05-16
Completion date
2025-12-08
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intratracheal Intubation, Patient Positioning

Keywords

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

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.

Interventions

BEHAVIORALDisengage the breathing circuit

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

Sponsors

Shandong Provincial Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Malposition rate of a double-lumen endobronchial tubeImmediately after a change in body positionDouble-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.

Secondary

MeasureTime frameDescription
Effects of lung collapse5 and 10 minutes after the pleura opensIf the lung on the operative side is completely atrophied and the surgical field is satisfied, it indicates that the degree of lung atrophy is good. The surgeon will score the quality of lung collapse using a four-point ordinal scale (1= extremelypoor-no collapse of lung; 2= poor-partial collapse of lung with interference with surgical exposure; 3= good-total collapse, but the lung still had some residual air; and 4= excellent-complete collapse of lung with perfect surgical exposure).
Blood oxygen saturation1 minute and 5 minutes after the change of position;1 minute, 5 minutes and 10 minutes after single-lung ventilationAn oxygen saturation below 94% is considered oxygen insufficiency
PACU length of stayThe time from the transfer to the PACU to the transfer out to ward, an average of an hourThe patient is awake and conscious

Countries

China

Contacts

PRINCIPAL_INVESTIGATORJin Bao Mao, Ph.D.

Shandong Provincial Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026