An interventional study of Bronchoscope guided advancement and Conventional advancement in Intubation, Intratracheal, Postoperative Complications and Sore Throat, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-10.
Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Prevention
Double lumen tube (DLT) needs to be intubated to isolate ventilations of left and right lungs for thoracic surgery. Post-operative sore throat and hoarseness are more frequent with DLT intubation than with single one. Which is may because DLT is relatively thicker, harder, sideway curved and therefore more likely to damage the vocal cord or trachea during intubation, and advanced deeper to the carina and main bronchus level. In the conventional method of intubation, DLT is rotated 90 degrees and advanced blindly to the main bronchus level after DLT is intubated through vocal cord using the direct laryngoscopy. After the blind advancement, the sufficient tube position needs to be gained and confirmed with the fiberoptic bronchoscope. In the bronchoscope guide method, after DLT is intubated through vocal cord using the direct laryngoscopy, the pathway into the targeted main bronchus is secured using the fiberoptic bronchoscope which is passed through a bronchial lumen of DLT. And then DLT can be advanced through the guide of the bronchoscope. In this study, we intend to compare post-operative sore throat, hoarseness and airway injury between the two methods. We hypothesize that the bronchoscope guide method can reduce the post-operative complications and airway injury because surrounding tissues of the airway can be less irritated by DLT intubation in the guide method than in a conventional.
For a constant guide effect, we use fiberoptic bronchoscopes with same outer diameter (4.1 mm) which can pass through a bronchial lumen of 37 and 39 Fr Lt. DLT and cannot pass through 35 Fr or smaller Lt. DLTs.
\<Lt. DLT size selection>
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's enrollment of 136 is above the median of 114 across 766 interventional studies indexed under Postoperative Complications.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DLT is advanced into the main bronchus through the guide of fiberoptic bronchoscope (Bronchoscope guided advancement).
Procedure: Bronchoscope guided advancement
DLT is advanced blindly to the main bronchus level (Conventional advancement).
Procedure: Conventional advancement
During the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the bronchoscope-guided method. The method is as follows. 1. Lt. DLT is intubated through vocal cord using the direct laryngoscopy. 2. Pass the fiberoptic bronschoscope through a bronchial lumen of Lt. DLT. 3. Secure the pathway into the Lt. main bronchus by advancing the bronchoscope into the Lt. main bronchus. 4. Lt. DLT can be advanced through the guide of the bronchoscope into Lt. main bronchus. 5. After the advancement, the position of Lt. DLT can be confirmed using the fiberoptic bronchoscope. If necessary, the depth and direction of Lt. DLT should be modified.
During the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the conventional method. The method is as follows. 1. Lt. DLT is intubated through vocal cord using the direct laryngoscopy. 2. Rotate Lt. DLT 90 degrees to the left side. 3. Advance Lt. DLT blindly to main bronchus level. 4. After the advancement, the position of Lt. DLT can be confirmed using the fiberoptic bronchoscope. If necessary, the depth and direction of Lt. DLT should be modified.
Post-operative sore throat (24 h)
The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most
Time frame: 24 hour after tracheal extubation
Resistance against DLT passage through vocal cord
none/mild/severe
Time frame: Intraoperative
Resistance against DLT advancement
none/mild/severe
Time frame: Intraoperative
Intubation time
stop of initial mask ventilation - intubation through vocal cord
Time frame: Intraoperative
The number of attempts for intubation
The number of attempts for intubation through vocal cord
Time frame: Intraoperative
The number of right misplacement of Lt. DLT
The number of right misplacement of Lt. DLT confirmed using the fiberoptic bronchoscope after the advancement
Time frame: Intraoperative
Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning
Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning into Lt. main bronchus
Time frame: Intraoperative
Heart rate
Heart rate Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
Time frame: Intraoperative
Mean arterial pressure
Mean arterial pressure Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
Time frame: Intraoperative
IV PCA
Fentanyl usage with PCA
Time frame: At 24 hours after the extubation
Airway injury (Lt. main bronhcus, carina, trachea)
When spontaneous breathing of the patient starts after the thoracic surgery
Time frame: Intraoperative
Airway injury (vocal cord)
When spontaneous breathing of the patient starts after the thoracic surgery
Time frame: Intraoperative
Post-operative sore throat (1 h)
The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most pain) after tracheal extubation
Time frame: 24 hours after tracheal extubation
Post-operative hoarseness (1 h)
The incidence of hoarseness after tracheal extubation
Time frame: 1 hour after tracheal extubation
Post-operative hoarseness (24 h)
The incidence of hoarseness after tracheal extubation
Time frame: 24 hour after tracheal extubation
Oral dryness
The incidence of oral dryness
Time frame: 24 hours after tracheal extubation
Dysphagia
The incidence of dysphagia
Time frame: 24 hours after tracheal extubation
Plan to share: No
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