Comparing Arndt and Tappa Endobronchial Blocker During Pediatric One Lung Ventilation

NCT05417256 | Unknown

• 1 other identifier: 2021/930
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 30 minutes

Secondary Outcomes (14)

• Lung collapse score

  Up to 30 minutes

• Difficulty of placement

  Up to 30 minutes

• Tidal volume

  Up to 120 minutes

• Respiratory rate

  Up to 120 minutes

• Peak airway pressure

  Up to 120 minutes

Study Arms (2)

Tappa Blocker Group

ACTIVE COMPARATOR

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.

Device: Tappa Endobronchial Blocker

Arndt Blocker Group

ACTIVE COMPARATOR

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.

Device: Arndt Endobronchial Blocker

Interventions

Tappa Endobronchial Blocker DEVICE

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.

Tappa Blocker Group

Arndt Endobronchial Blocker DEVICE

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.

Arndt Blocker Group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 31068034 BACKGROUND

• 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.

  PMID: 31852095 RESULT

• 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.

  PMID: 24163446 RESULT

• 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.

  PMID: 1155755 RESULT

• 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.

  PMID: 15486004 RESULT

Related Links

• Selective pulmonary lobe isolation with Arndt pediatric endobronchial blocker for an infant
• One lung ventilation strategies for infants and children undergoing video assisted thoracoscopic surgery
• Selective bronchial blocking in children
• Experience with the Arndt paediatric bronchial blocker
• Successful one-lung ventilation by blocking the right intermediate bronchus in a 7-year-old child: a case report

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Meltem Savran Karadeniz, Assoc Prof

  Istanbul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meltem Savran Karadeniz, Assoc Prof

CONTACT

02126318767; mskaradeniz@gmail.com

Suna Arat, Dr

CONTACT

05399833797; suna_arat@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 14, 2022
• Study Start: July 25, 2022
• Primary Completion: December 25, 2022
• Study Completion: October 20, 2023
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

TU (1)