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

Intratracheal Intubation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06182371
• Other study ID #: MLv
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: Shandong Provincial Hospital
• Contact: Meng Lv, Ph.D.
• Phone: 15169105373
• Email: qylvmeng[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: January 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intratracheal Intubation
• Patient Positioning
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Partial pressure of carbon dioxide at the end of expiration	Determine the status of blood-lung ventilation and pulmonary blood flow	1 minute and 5 minutes after the change of position;1 minute, 5 minutes and 10 minutes after single-lung ventilation
Other	Blood pressure	Make sure the patient's blood pressure is within the normal range	1 minute and 5 minutes after the change of position;1 minute, 5 minutes and 10 minutes after single-lung ventilation
Other	Heart rate	Make sure the patient's heart rate is within the normal range	1 minute and 5 minutes after the change of position;1 minute, 5 minutes and 10 minutes after single-lung ventilation
Primary	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	Effects of lung collapse	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).	5 and 10 minutes after the pleura opens
Secondary	Blood oxygen saturation	An oxygen saturation below 94% is considered oxygen insufficiency	1 minute and 5 minutes after the change of position;1 minute, 5 minutes and 10 minutes after single-lung ventilation
Secondary	PACU length of stay	The patient is awake and conscious	The time from the transfer to the PACU to the transfer out to ward, an average of an hour