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Comparing Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation

Primary Purpose

Lung Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tappa Endobronchial Blocker
Arndt Endobronchial Blocker
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases focused on measuring Arndt endobronchial blocker, Tappa endobronchial blocker, Pediatrics, One lung ventilation, Thoracic Surgery

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tappa Blocker Group

Arndt Blocker Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Time from laryngoscopy to placement of the bronchial blocker
Time from laryngoscopy to correct insertion of the bronchial blocker by an experienced anaesthetist will be recorded.

Secondary Outcome Measures

Lung collapse score
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
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.
Tidal volume
Volume of gas delivered during each ventilator breath.
Respiratory rate
Number of breaths delivered by the ventilator per minute.
Peak airway pressure
Pressure used to deliver tidal volume by overcoming resistance in airways and lungs .
Plateau pressure
End inspiratory pressure during a period with no gas flow in the circuit.
Compliance
Change in volume of the lung produced by a change in pressure across the lung.
Partial pressure of oxygen
Measurement of oxygen pressure in arterial blood.
Partial pressure of carbon dioxide
Measurement of carbon dioxide pressure in arterial blood.
Lactate
Lactate levels in arterial blood gas is used to evaluate tissue perfusion.
Frequency of malposition of the bronchial blocker
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) stay
If the patients stay in ICU postoperatively
First mobilitisition time
First mobilitisition time
Length of hospital stay
Length of hospital stay

Full Information

First Posted
June 5, 2022
Last Updated
June 9, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05417256
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 25, 2022 (Anticipated)
Primary Completion Date
December 25, 2022 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
Arndt endobronchial blocker, Tappa endobronchial blocker, Pediatrics, One lung ventilation, Thoracic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tappa Blocker Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Arndt Blocker Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Tappa Endobronchial Blocker
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Arndt Endobronchial Blocker
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time from laryngoscopy to placement of the bronchial blocker
Description
Time from laryngoscopy to correct insertion of the bronchial blocker by an experienced anaesthetist will be recorded.
Time Frame
Up to 30 minutes
Secondary Outcome Measure Information:
Title
Lung collapse score
Description
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.
Time Frame
Up to 30 minutes
Title
Difficulty of placement
Description
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.
Time Frame
Up to 30 minutes
Title
Tidal volume
Description
Volume of gas delivered during each ventilator breath.
Time Frame
Up to 120 minutes
Title
Respiratory rate
Description
Number of breaths delivered by the ventilator per minute.
Time Frame
Up to 120 minutes
Title
Peak airway pressure
Description
Pressure used to deliver tidal volume by overcoming resistance in airways and lungs .
Time Frame
Up to 120 minutes
Title
Plateau pressure
Description
End inspiratory pressure during a period with no gas flow in the circuit.
Time Frame
Up to 120 minutes
Title
Compliance
Description
Change in volume of the lung produced by a change in pressure across the lung.
Time Frame
Up to 120 minutes
Title
Partial pressure of oxygen
Description
Measurement of oxygen pressure in arterial blood.
Time Frame
At 15 minutes after initiation of one lung ventilation.
Title
Partial pressure of carbon dioxide
Description
Measurement of carbon dioxide pressure in arterial blood.
Time Frame
At 15 minutes after initiation of one lung ventilation.
Title
Lactate
Description
Lactate levels in arterial blood gas is used to evaluate tissue perfusion.
Time Frame
At 15 minutes after initiation of one lung ventilation.
Title
Frequency of malposition of the bronchial blocker
Description
Frequency of malposition of the bronchial blocker after successful bronchial blocker placement will be recorded if the blocker displaces.
Time Frame
Up to the end of one lung ventilation intraoperatively.
Title
Length of intensive care unit (ICU) stay
Description
If the patients stay in ICU postoperatively
Time Frame
Up to 48 hours
Title
First mobilitisition time
Description
First mobilitisition time
Time Frame
Up to 24 hours
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
Up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meltem Savran Karadeniz, Assoc Prof
Phone
02126318767
Email
mskaradeniz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suna Arat, Dr
Phone
05399833797
Email
suna_arat@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem Savran Karadeniz, Assoc Prof
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meltem Savran Karadeniz, Assoc Prof
Phone
02126318767
Email
mskaradeniz@gmail.com
First Name & Middle Initial & Last Name & Degree
Suna Arat, Dr
Phone
05399833797
Email
suna_arat@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31068034
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.
Results Reference
background
PubMed Identifier
31852095
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.
Results Reference
result
PubMed Identifier
24163446
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.
Results Reference
result
PubMed Identifier
1155755
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.
Results Reference
result
PubMed Identifier
15486004
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6922580/
Description
Selective pulmonary lobe isolation with Arndt pediatric endobronchial blocker for an infant
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3800324/
Description
One lung ventilation strategies for infants and children undergoing video assisted thoracoscopic surgery
URL
http://pubmed.ncbi.nlm.nih.gov/1155755/
Description
Selective bronchial blocking in children
URL
http://pubmed.ncbi.nlm.nih.gov/15486004/
Description
Experience with the Arndt paediatric bronchial blocker
URL
http://pubmed.ncbi.nlm.nih.gov/31068034/
Description
Successful one-lung ventilation by blocking the right intermediate bronchus in a 7-year-old child: a case report

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Comparing Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation

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