Comparing Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation

Not Applicable

• Conditions: Lung Diseases
• Interventions: Device: Arndt Endobronchial Blocker; Device: Tappa Endobronchial Blocker

• Registration Number: NCT05417256
• Lead Sponsor: Istanbul University

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).

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Study Start: 2022-07-25
• Primary Completion: 2022-12-25
• Study Completion: 2023-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arndt Blocker Group	Arndt Endobronchial Blocker	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.
Tappa Blocker Group	Tappa Endobronchial Blocker	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.

Primary Outcome Measures

Name	Time	Method
Time from laryngoscopy to placement of the bronchial blocker	Up to 30 minutes	Time from laryngoscopy to correct insertion of the bronchial blocker by an experienced anaesthetist will be recorded.

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	Up to 120 minutes	Number of breaths delivered by the ventilator per minute.
Peak airway pressure	Up to 120 minutes	Pressure used to deliver tidal volume by overcoming resistance in airways and lungs .
Plateau pressure	Up to 120 minutes	End inspiratory pressure during a period with no gas flow in the circuit.
Lung collapse score	Up to 30 minutes	Lung collapse will be assesed at 5,10,15,and 20 minutes after pleural opening using a 10-point scale by the surgeon. 1 point refers to the inflated lung and 10 point refers to a completely collapsed lung.
Difficulty of placement	Up to 30 minutes	The anaesthetist will rate the difficulty of placement of the bronchial blocker using a 5-point scale, 1 point being very easy and 5 points being impossible to insert.
Lactate	At 15 minutes after initiation of one lung ventilation.	Lactate levels in arterial blood gas is used to evaluate tissue perfusion.
Frequency of malposition of the bronchial blocker	Up to the end of one lung ventilation intraoperatively.	Frequency of malposition of the bronchial blocker after successful bronchial blocker placement will be recorded if the blocker displaces.
First mobilitisition time	Up to 24 hours	First mobilitisition time
Partial pressure of oxygen	At 15 minutes after initiation of one lung ventilation.	Measurement of oxygen pressure in arterial blood.
Tidal volume	Up to 120 minutes	Volume of gas delivered during each ventilator breath.
Partial pressure of carbon dioxide	At 15 minutes after initiation of one lung ventilation.	Measurement of carbon dioxide pressure in arterial blood.
Length of intensive care unit (ICU) stay	Up to 48 hours	If the patients stay in ICU postoperatively
Compliance	Up to 120 minutes	Change in volume of the lung produced by a change in pressure across the lung.
Length of hospital stay	Up to 1 week	Length of hospital stay

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Istanbul, Turkey