Clinical trial NCT05417256: Comparing Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation
Official title: A Prospective Randomized Trial Comparing the Application of Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Diseases
Keywords: Arndt endobronchial blocker
Tappa endobronchial blocker
Pediatrics
One lung ventilation
Thoracic Surgery
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 26
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and ease of placement of two different endobronchial blockers(Arndt and Tappa blocker) for pediatric patients undergoing thoracotomy. Time from laryngoscopy to successful insertion of the blocker by an experienced anaesthetist will be recorded and the difficulty of placement of the blocker will be assesed. We plan to evaluate the lung collapse and also observe the effect of two different bronchial blockers on patients' ventilation and oxygenation and adverse events such as desaturation, failed one lung ventilation.Our primary outcome is the time from laryngoscopy to successful insertion of the bronchial blocker by an experienced anaesthetist. Our secondary outcomes are effects of two different bronchial blockers on lung isolation score, ease of placement of the bronchial blocker, mechanical ventilation parameters (tidal volume, respiratory rate, peak airway pressure, plateau pressure, compliance), intraoperative blood gas analysis (paO2, pCO2, saO2, lac), frequency of malposition after successful blocker placement, surgical exposure and complications.

Detailed description: Many techniques for one lung ventilation exist including the use of double-lumen tubes, endotracheal tubes and bronchial blockers. The choice of lung isolation technique depends on the age, the size of the patient, experience of the anaesthetist and type of the surgery. The use of double lumen tube for one lung ventilation is very common. However, it may be challenging and hazardous in some cases such as pediatric patients, patients with tracheostomy, difficult airway scenarios. Endobronchial blockers can be used for these cases. Bronchial blockers have high-volume,low-pressure balloons so they are less likely to cause damage to the airway mucosa while achieving a successful lung isolation. Arndt blocker has a low-pressure, high-volume balloon, a multiport airway adapter and a guide loop. On the other hand, Tappa bronchial blocker has an auto inflation balloon, and a high volume low pressure cuff. It also has 'Tappa angle' which is designed as per human anatomy which makes it easier to insert.

In our study, we aim to compare the efficacy and ease of placement of Arndt and Tappa blocker for pediatric one lung ventilation. Our primary outcome is the time from laryngoscopy to successful insertion of the bronchial blocker by an experienced anaesthetist. Secondary outcomes are effects of two different bronchial blockers on lung isolation score, ease of placement of the bronchial blocker, mechanical ventilation parameters (tidal volume, respiratory rate, peak airway pressure, plateau pressure, compliance), intraoperative blood gas analysis (paO2, pCO2, saO2, lac), frequency of malposition after successful blocker placement, surgical exposure and complications. The difficulty of placement of the blocker will be assesed by a 5-point scale (1:very easy, 5:impossible) and the lung collapse will be evaluated by using a 10-point scale (10: complete collapse).

Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing thoracic surgery
* American Society of Anesthesiology Class 1-2-3

Exclusion Criteria:

* Denial of patients or parents
* Coagulopathy
* With preexisting cardiac dysfunction
* Wtih history of renal and/or hepatic dysfunction

Primary outcomes:
measure: Time from laryngoscopy to placement of the bronchial blocker
timeFrame: Up to 30 minutes
Secondary outcomes:
measure: Lung collapse score
timeFrame: Up to 30 minutes
measure: Difficulty of placement
timeFrame: Up to 30 minutes
measure: Tidal volume
timeFrame: Up to 120 minutes
measure: Respiratory rate
timeFrame: Up to 120 minutes
measure: Peak airway pressure
timeFrame: Up to 120 minutes
measure: Plateau pressure
timeFrame: Up to 120 minutes
measure: Compliance
timeFrame: Up to 120 minutes
measure: Partial pressure of oxygen
timeFrame: At 15 minutes after initiation of one lung ventilation.
measure: Partial pressure of carbon dioxide
timeFrame: At 15 minutes after initiation of one lung ventilation.
measure: Lactate
timeFrame: At 15 minutes after initiation of one lung ventilation.
measure: Frequency of malposition of the bronchial blocker
timeFrame: Up to the end of one lung ventilation intraoperatively.
measure: Length of intensive care unit (ICU) stay
timeFrame: Up to 48 hours
measure: First mobilitisition time
timeFrame: Up to 24 hours
measure: Length of hospital stay
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: Meltem Savran Karadeniz, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baek SY, Kim JH, Kim G, Choi JH, Jeong CY, Ryu KH, Park DH. Successful one-lung ventilation by blocking the right intermediate bronchus in a 7-year-old child: a case report. J Int Med Res. 2019 Jun;47(6):2740-2745. doi: 10.1177/0300060519845782. Epub 2019 May 8.
citation: Wu C, Liang X, Liu B. Selective pulmonary lobe isolation with Arndt pediatric endobronchial blocker for an infant: A case report. Medicine (Baltimore). 2019 Dec;98(50):e18262. doi: 10.1097/MD.0000000000018262.
citation: Fabila TS, Menghraj SJ. One lung ventilation strategies for infants and children undergoing video assisted thoracoscopic surgery. Indian J Anaesth. 2013 Jul;57(4):339-44. doi: 10.4103/0019-5049.118539.
citation: Cay DL, Csenderits LE, Lines V, Lomaz JG, Overton JH. Selective bronchial blocking in children. Anaesth Intensive Care. 1975 May;3(2):127-30. doi: 10.1177/0310057X7500300208.
citation: Wald SH, Mahajan A, Kaplan MB, Atkinson JB. Experience with the Arndt paediatric bronchial blocker. Br J Anaesth. 2005 Jan;94(1):92-4. doi: 10.1093/bja/aeh292. Epub 2004 Oct 14.