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NCT Number: NCT06182371

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

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.

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Key information

Conditions

Intratracheal Intubation Patient Positioning

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, S, 250021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Disengage the breathing circuit

Behavioral

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

Primary outcomes

  1. Malposition rate of a double-lumen endobronchial tube

    Time frame: Immediately after a change in body position

    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.

Secondary outcomes

  1. Effects of lung collapse

    Time frame: 5 and 10 minutes after the pleura opens

    If 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).

  2. Blood oxygen saturation

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

    An oxygen saturation below 94% is considered oxygen insufficiency

  3. PACU length of stay

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

    The patient is awake and conscious

Other outcomes

  1. Partial pressure of carbon dioxide at the end of expiration

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

    Determine the status of blood-lung ventilation and pulmonary blood flow

  2. Blood pressure

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

    Make sure the patient's blood pressure is within the normal range

  3. Heart rate

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

    Make sure the patient's heart rate is within the normal range

Sponsors and collaborators

Lead sponsor

Shandong Provincial Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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