Effect of the Minimum Bronchial Cuff Volume of Left-sided Double-lumen Endotracheal Tube for One-lung Ventilation on the Change of the Bronchial Cuff Pressure During Lateral Positioning in Thoracic Surgery

NCT ID: NCT05222568

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-12

Study Completion Date

2021-12-31

Brief Summary

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Over-inflation of the bronchial cuff of the double-lumen tube (DLT) can cause damage to the airway mucosa and misplacement of the tube, and under-inflation may cause incomplete collapse of the non-ventilated lung and incomplete ventilation of the lung that should be ventilated. Appropriate cuff pressure is generally known to be ranged 20-30 cmH₂O, but in the study of Okubo et al., who observed the minimum bronchial cuff volume and pressure that did not cause air leakage using the method of confirming by capnography, it was possible to obtain the result that OLV was possible without air leakage even at a pressure lower than 25 cmH₂O (the generally recommended tube cuff pressure) in both men and women. In a recent study of Yamada et al., when using the capnography waveform-guided method to inflate the bronchial cuff by checking for air leakage using the capnography waveform, the bronchial cuff volume (BCV) that satisfies the air-tight seal was significantly smaller compared with a pressure-guided method to inflate the bronchial cuff with 20 cmH₂O.

The minimum bronchial cuff volume (BCVmin) at which such air leakage does not occur may vary from individual to individual. It is presumed that this is because the diameter of the left main bronchus (LMB) differs from individual to individual, which causes the variation of the gap between the diameter of the LMB and the outer diameter of the DLT mounted thereon. Moreover, the previous study revealed that the lateral positioning could increase the pressure of the bronchial cuff mounted on the LMB due to the gravity-induced morphological and conformational change of the trachea. Considering these factors, the researchers hypothesized that the change in the bronchial cuff pressure (BCP) due to a positional change might vary depending on whether the bronchial cuff was inflated, that is, the initially established BCVmin.

Therefore, in this study, the researchers tried to investigate the effect of BCVmin on the change of minimum bronchial cuff pressure (BCPmin) due to the positional change from the supine to lateral decubitus, by dividing the groups whose BCVmin is 0 ml or exceeds 0 ml.

Detailed Description

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Conditions

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Lung Cancer Pneumothorax

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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BCVmin=0

This study was a prospective observational study, and the patients was divided into two groups with BCVmin=0 or BCVmin \>0, according to the BCVmin which was naturally determined during anesthesia in each patient.

Lateral positioning

Intervention Type BEHAVIORAL

After the DLT intubation, the patient is placed in lateral decubitus position

Cuff pressure measurement

Intervention Type DEVICE

The pressure of the bronchial cuff should be measured with cuff-manometer in supine position, and then measurement should be repeated after lateral positioning

BCVmin>0

The patients was divided into two groups with BCVmin=0 or BCVmin \>0, according to the BCVmin which was naturally determined during anesthesia in each patient.

Lateral positioning

Intervention Type BEHAVIORAL

After the DLT intubation, the patient is placed in lateral decubitus position

Cuff pressure measurement

Intervention Type DEVICE

The pressure of the bronchial cuff should be measured with cuff-manometer in supine position, and then measurement should be repeated after lateral positioning

Interventions

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Lateral positioning

After the DLT intubation, the patient is placed in lateral decubitus position

Intervention Type BEHAVIORAL

Cuff pressure measurement

The pressure of the bronchial cuff should be measured with cuff-manometer in supine position, and then measurement should be repeated after lateral positioning

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients aged 18-80 and with an American Society of Anesthesiologists (ASA) physical status of 1 or 3 who are scheduled to undergo elective video-assisted thoracoscopic surgery (VATS)

Exclusion Criteria

A. Need for a right-sided DLT B. An intraluminal lesion in the left main bronchus C. An anatomical problem in the tracheobronchial tree D. Patients with chronic obstructive pulmonary disease with impaired lung compliance E. Patients with interstitial lung disease with severe pulmonary dysfunction F. Patients with Body mass index (BMI) ≥ 30
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Chilgok Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sung Hye Byun

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung-Hye Byun, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Chilgok Hospital

Locations

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Sung Hye Byun

Daegu, , South Korea

Site Status

Countries

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South Korea

References

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Tobias JD. Pediatric airway anatomy may not be what we thought: implications for clinical practice and the use of cuffed endotracheal tubes. Paediatr Anaesth. 2015 Jan;25(1):9-19. doi: 10.1111/pan.12528. Epub 2014 Sep 20.

Reference Type BACKGROUND
PMID: 25243638 (View on PubMed)

Kim JH, Kim E, Kim IY, Choi EJ, Byun SH. Changes in the Bronchial Cuff Pressure of Left-Sided Double-Lumen Endotracheal Tube by Lateral Positioning: A Prospective Observational Study. J Clin Med. 2021 Apr 9;10(8):1590. doi: 10.3390/jcm10081590.

Reference Type BACKGROUND
PMID: 33918748 (View on PubMed)

Yuceyar L, Kaynak K, Canturk E, Aykac B. Bronchial rupture with a left-sided polyvinylchloride double-lumen tube. Acta Anaesthesiol Scand. 2003 May;47(5):622-5. doi: 10.1034/j.1399-6576.2003.00102.x.

Reference Type BACKGROUND
PMID: 12699525 (View on PubMed)

Hannallah MS, Benumof JL, McCarthy PO, Liang M. Comparison of three techniques to inflate the bronchial cuff of left polyvinylchloride double-lumen tubes. Anesth Analg. 1993 Nov;77(5):990-4. doi: 10.1213/00000539-199311000-00020.

Reference Type BACKGROUND
PMID: 8214739 (View on PubMed)

Sultan P, Carvalho B, Rose BO, Cregg R. Endotracheal tube cuff pressure monitoring: a review of the evidence. J Perioper Pract. 2011 Nov;21(11):379-86. doi: 10.1177/175045891102101103.

Reference Type BACKGROUND
PMID: 22165491 (View on PubMed)

Okubo H, Kawasaki T, Shibayama A, Sata T. [Measurement of the Minimum Pressure in the Bronchial Cuff during One-lung Ventilation Using a Capnometer]. Masui. 2015 Aug;64(8):794-8. Japanese.

Reference Type BACKGROUND
PMID: 26442408 (View on PubMed)

Yamada Y, Tanabe K, Nagase K, Ishihara T, Iida H. A Comparison of the Required Bronchial Cuff Volume Obtained by 2 Cuff Inflation Methods, Capnogram Waveform-Guided Versus Pressure-Guided: A Prospective Randomized Controlled Study. Anesth Analg. 2021 Mar 1;132(3):827-835. doi: 10.1213/ANE.0000000000005179.

Reference Type BACKGROUND
PMID: 33002924 (View on PubMed)

Other Identifiers

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KNUCH 2021-08-059-001

Identifier Type: -

Identifier Source: org_study_id

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