Comparing Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation

Istanbul University

Status: Not yet enrolling

Conditions: Lung Diseases

Treatments: Device: Tappa Endobronchial Blocker; Device: Arndt Endobronchial Blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT05417256

2021/930

Details and patient eligibility

About

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.

Full 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).

Enrollment: 26 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Tappa Blocker Group

Active Comparator group

Description:

After orotracheal intubation, Tappa endobronchial blocker will be inserted using a broncoscope by an experienced anaesthetist. Time from laryngoscopy to successful placement of the endobronchial blocker will be recorded.

Treatment:

Device: Tappa Endobronchial Blocker

Arndt Blocker Group

Active Comparator group

Description:

After orotracheal intubation, Arndt endobronchial blocker will be inserted using a broncoscope by the experienced anaesthetist. Time from laryngoscopy to successful placement of the endobronchial blocker will be recorded.

Treatment:

Device: Arndt Endobronchial Blocker