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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Shandong Provincial Hospital
- Enrollment
- 256
- Primary Endpoint
- Malposition rate of a double-lumen endobronchial tube
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: Disengage the breathing circuit (Behavioral)
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.
Outcomes
Primary Outcomes
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
- PACU length of stay(The time from the transfer to the PACU to the transfer out to ward, an average of an hour)
- Effects of lung collapse(5 and 10 minutes after the pleura opens)
- Blood oxygen saturation(1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation)
Investigators
Meng Lv
Deputy Chief Physician
Shandong Provincial Hospital