Clinical trial NCT06182371: Effectiveness of Detachment of the Breathing Circuit on the Rate of DLT Malposition After Postural Change
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intratracheal Intubation
Patient Positioning
Keywords: Double-Lumen Endobronchial Tube
Positional changes
Disengage
Breathing circuit
Malposition
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-26
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Malposition rate of a double-lumen endobronchial tube
timeFrame: Immediately after a change in body position
Secondary outcomes:
measure: Effects of lung collapse
timeFrame: 5 and 10 minutes after the pleura opens
measure: Blood oxygen saturation
timeFrame: 1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation
measure: PACU length of stay
timeFrame: The time from the transfer to the PACU to the transfer out to ward, an average of an hour
Other outcomes:
measure: Partial pressure of carbon dioxide at the end of expiration
timeFrame: 1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation
measure: Blood pressure
timeFrame: 1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation
measure: Heart rate
timeFrame: 1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation
Locations:
Study officials:
affiliation: Shandong Provincial Hospital
name: Jin Bao Mao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: