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Comparing Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation

A Prospective Randomized Trial Comparing the Application of Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05417256
Enrollment
26
Registered
2022-06-14
Start date
2022-07-25
Completion date
2023-10-20
Last updated
2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

Keywords

Arndt endobronchial blocker, Tappa endobronchial blocker, Pediatrics, One lung ventilation, Thoracic Surgery

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).

Interventions

DEVICETappa Endobronchial Blocker

After intubation, the Tappa bronchial blocker will be advanced either through the intubation tube or outside the tube using a fiberoptic broncoscope. Once the position of the blocker is confirmed, the cuff of the blocker will be inflated with 1-3 mL of air. Since Tappa blocker has an autoinflation system, the anaesthetist can both inflate the cuff with one hand and operate the fiberoptic broncoscope at the same time.

DEVICEArndt Endobronchial Blocker

After intubation, the endobronchial blocker will be passed through a multiport airway adapter that is placed at the proximal end of the tracheal tube.The fiberoptic broncoscope will be passed through the port and then through the guidewire loop at the end of the blocker. The bronchial blocker and the broncoscope will be advanced as a single unit into the target part of a right or left lung. The broncoscope will be withdrawn into the trachea and the blocker cuff will be inflated and the position of the blocker will be confirmed using the fiberoptic broncoscope. The wire loop will be removed after correct placement of the blocker. Once the guide wire is removed, the blocker can't be replaced.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time from laryngoscopy to placement of the bronchial blockerUp to 30 minutesTime from laryngoscopy to correct insertion of the bronchial blocker by an experienced anaesthetist will be recorded.

Secondary

MeasureTime frameDescription
Difficulty of placementUp to 30 minutesThe 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.
Tidal volumeUp to 120 minutesVolume of gas delivered during each ventilator breath.
Respiratory rateUp to 120 minutesNumber of breaths delivered by the ventilator per minute.
Peak airway pressureUp to 120 minutesPressure used to deliver tidal volume by overcoming resistance in airways and lungs .
Plateau pressureUp to 120 minutesEnd inspiratory pressure during a period with no gas flow in the circuit.
ComplianceUp to 120 minutesChange in volume of the lung produced by a change in pressure across the lung.
Lung collapse scoreUp to 30 minutesLung 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.
Partial pressure of carbon dioxideAt 15 minutes after initiation of one lung ventilation.Measurement of carbon dioxide pressure in arterial blood.
LactateAt 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 blockerUp 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.
Length of intensive care unit (ICU) stayUp to 48 hoursIf the patients stay in ICU postoperatively
First mobilitisition timeUp to 24 hoursFirst mobilitisition time
Length of hospital stayUp to 1 weekLength of hospital stay
Partial pressure of oxygenAt 15 minutes after initiation of one lung ventilation.Measurement of oxygen pressure in arterial blood.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMeltem Savran Karadeniz, Assoc Prof
mskaradeniz@gmail.com02126318767
Backup ContactSuna Arat, Dr
suna_arat@hotmail.com05399833797

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026