Clinical trial NCT03656406: Effect of Lateral Positioning on Bronchial Cuff Pressure of Left-sided Double-lumen Endotracheal Tube During Thoracic Surgery
Official title: Effect of Lateral Positioning on Bronchial Cuff Pressure of Left-sided Double-lumen Endotracheal Tube During Thoracic Surgery: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Pneumothorax
Keywords: Double-lumen endotracheal tube
Cuff pressure
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
Collaborators: name: Research Institute of Medical Science, Daegu Catholic University
First posted: 2018-09-04
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-70 years with an American Society of Anesthesiologists (ASA) physical status 1 or 2, who are scheduled to undergo elective lung surgery requiring lateral decubitus positioning and one-lung ventilation (OLV) using left-sided DLT

Brief summary: The investigators evaluate the effect of postural change on the bronchial cuff pressure (BCP) of double-lumen endotracheal tube (DLT) in patients undergoing thoracic surgery, by observing the pressure of the bronchial cuff before and after lateral decubitus positioning.

Detailed description: It is essential to maintain proper cuff pressure in the endotracheal tube (ETT) when placing the ETT in the trachea in patients undergoing general anesthesia. Most of the literature recommend maintaining a pressure of 20-30 cmH2O to prevent cuff-related complications such as micro-aspiration or airway trauma. Proper pressure is also important for DLTs used in thoracic surgery. Furthermore, the cuff pressure of the ETT can change during the patient's positional changes. All things considered, we hypothesized that the change from supine to lateral decubitus position, which is essential for thoracic surgery would affect the BCP of the DLT.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1 or 2
2. Elective lung surgery requiring lateral decubitus positioning and one-lung ventilation using left-sided DLT

Exclusion Criteria:

1. Patients requiring a right-sided DLT.
2. Patients with an intraluminal lesion in the left mainstem bronchus (LMB).
3. Patients with an anatomical problem in the tracheobronchial tree.
4. Patients with impaired lung such as chronic obstructive pulmonary disease.
5. Patients who refused to participate in this study.

Primary outcomes:
measure: Change of the maximum bronchial cuff pressure (BCP) which does not exceed 40 cmH2O with no air leak from supine to lateral decubitus position
timeFrame: 1. In supine position, 2 minutes after the completion of confirming the double-lumen endotracheal tube (DLT) position via fiberoptic bronchoscope (FOB) 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
Secondary outcomes:
measure: The incidence of the patients whose maximum BCP exceed 40 cmH2O after lateral positioning
timeFrame: 1. In supine position, 2 minutes after the completion of confirming the DLT position via FOB 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
measure: The minimum BCV that is the smallest bronchial cuff volume without air leakage
timeFrame: 1. In supine position, 2 minutes after the completion of confirming the DLT position via FOB 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Sung-Hye Byun
Study officials:
References:
citation: Wu CY, Yeh YC, Wang MC, Lai CH, Fan SZ. Changes in endotracheal tube cuff pressure during laparoscopic surgery in head-up or head-down position. BMC Anesthesiol. 2014 Aug 31;14:75. doi: 10.1186/1471-2253-14-75. eCollection 2014.
citation: Athiraman U, Gupta R, Singh G. Endotracheal cuff pressure changes with change in position in neurosurgical patients. Int J Crit Illn Inj Sci. 2015 Oct-Dec;5(4):237-41. doi: 10.4103/2229-5151.170841.
citation: Araki K, Nomura R, Urushibara R, Yoshikawa Y, Hatano Y. Bronchial cuff pressure change caused by left-sided double-lumen endobronchial tube displacement. Can J Anaesth. 2000 Aug;47(8):775-9. doi: 10.1007/BF03019480.
citation: Kim E, Kim IY, Byun SH. Effect of lateral positioning on the bronchial cuff pressure of a left-sided double-lumen endotracheal tube during thoracic surgery: study protocol for a prospective observational study. BMJ Open. 2019 Mar 30;9(3):e026606. doi: 10.1136/bmjopen-2018-026606.