Pediatric Neck Rescue Access Comparison

NCT ID: NCT05499273

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2023-03-08

Brief Summary

Two recent studies explored the emergency tracheotomy technique and the scalpel-bougie-tracheostomy technique as a neck rescue access for newborns and infants on a rabbit cadaver. Both studies lacked a key feature of real surgical access - bleeding during a true emergency. The study's objective was to comparatively assess the two techniques in a simulated environment with simulated bleeding and decreasing vital signs from the monitor like in real emergencies.

Detailed Description

With ethical committee's approval the investigarors recruited for this cross-over trial pediatric anesthesiologists and intensivists. Emergency tracheotomy consists of four steps: vertical skin incision, strap muscles separation (2 Backhaus clamps), anterior luxation of the trachea with a 3rd clamp, and vertical puncture with tip-scissors of no more than 2 tracheal rings to insert the tube. The scalpel-bougie-tracheostomy involves separation of neck tissues to expose the trachea and tracheal incision both with a scalpel to insert the bougie to facilitate tracheal intubation. Participants were randomized to start either with emergency tracheotomy or scalpel-bougie-tracheostomy. They watched an instructional video and had four practicing attempts, followed by a fifth attempt which was assessed. Afterward, they crossed over to the other technique.

Conditions

Tracheostomy Complication; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

scalpel-bougie tracheostomy (SBT)

SBT technique described in Interventions

Group Type: ACTIVE_COMPARATOR

scalpel-bougie tracheostomy

Intervention Type: PROCEDURE

1. The assistant places themselves with two preparation clamps at the head end of the table and assists with each hand placed lateral to the neck, so that the operating field is freely accessible. After the trachea or cricoid is palpated, a long median longitudinal skin incision of 2-3 cm is made from the cricoid caudally

2. The assistant uses straight clamps to pull the two edges of the skin incision apart dorso-laterally. In the event of major bleeding this maneuver should allow the blood to drain off dorsally and the view of the anatomical structures should be less impaired.

3. Layer by layer of the anatomical structures are cut through with the scalpel and tightened with the clamps accordingly.

4. Using a longitudinal incision, two to three tracheal rings are cut through distally to the cricoid

5. An 8 FR Frova catheter is inserted through the orifice into trachea.

6. A tracheal tube (ID 3.0 mm) is inserted over the Frova catheter to secure the airway permanently.

rapid sequence tracheotomy

Intervention Type: PROCEDURE

1. Orientational palpation and vertical midline skin incision followed by separation of the strap muscles

2. Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp

3. Perform a vertical puncture with a tip scissors between the cricoid and 1st tracheal ring followed by a vertical incision of no more than 2 rings in length.

4. A tracheal tube (inner diameter 3.0 mm, cuffed) is inserted to secure the airway permanently.

rapid sequence tracheotomy (RST

RST technique described in Interventions

Group Type: ACTIVE_COMPARATOR

scalpel-bougie tracheostomy

Intervention Type: PROCEDURE

1. The assistant places themselves with two preparation clamps at the head end of the table and assists with each hand placed lateral to the neck, so that the operating field is freely accessible. After the trachea or cricoid is palpated, a long median longitudinal skin incision of 2-3 cm is made from the cricoid caudally

2. The assistant uses straight clamps to pull the two edges of the skin incision apart dorso-laterally. In the event of major bleeding this maneuver should allow the blood to drain off dorsally and the view of the anatomical structures should be less impaired.

3. Layer by layer of the anatomical structures are cut through with the scalpel and tightened with the clamps accordingly.

4. Using a longitudinal incision, two to three tracheal rings are cut through distally to the cricoid

5. An 8 FR Frova catheter is inserted through the orifice into trachea.

6. A tracheal tube (ID 3.0 mm) is inserted over the Frova catheter to secure the airway permanently.

rapid sequence tracheotomy

Intervention Type: PROCEDURE

1. Orientational palpation and vertical midline skin incision followed by separation of the strap muscles

2. Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp

3. Perform a vertical puncture with a tip scissors between the cricoid and 1st tracheal ring followed by a vertical incision of no more than 2 rings in length.

4. A tracheal tube (inner diameter 3.0 mm, cuffed) is inserted to secure the airway permanently.

Interventions

scalpel-bougie tracheostomy

1. The assistant places themselves with two preparation clamps at the head end of the table and assists with each hand placed lateral to the neck, so that the operating field is freely accessible. After the trachea or cricoid is palpated, a long median longitudinal skin incision of 2-3 cm is made from the cricoid caudally

2. The assistant uses straight clamps to pull the two edges of the skin incision apart dorso-laterally. In the event of major bleeding this maneuver should allow the blood to drain off dorsally and the view of the anatomical structures should be less impaired.

3. Layer by layer of the anatomical structures are cut through with the scalpel and tightened with the clamps accordingly.

4. Using a longitudinal incision, two to three tracheal rings are cut through distally to the cricoid

5. An 8 FR Frova catheter is inserted through the orifice into trachea.

6. A tracheal tube (ID 3.0 mm) is inserted over the Frova catheter to secure the airway permanently.

Intervention Type: PROCEDURE

rapid sequence tracheotomy

1. Orientational palpation and vertical midline skin incision followed by separation of the strap muscles

2. Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp

3. Perform a vertical puncture with a tip scissors between the cricoid and 1st tracheal ring followed by a vertical incision of no more than 2 rings in length.

4. A tracheal tube (inner diameter 3.0 mm, cuffed) is inserted to secure the airway permanently.

Intervention Type: PROCEDURE

Other Intervention Names

SBT; RST

Eligibility Criteria

Inclusion Criteria

• board certified pediatric anesthesiologists or pediatric intensive care doctor
• informed consent signed

Exclusion Criteria

• none

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gaslini Children's Hospital

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Thomas Riva

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Riva, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

University Hospital Bern

Bern, , Switzerland

Countries

Switzerland

References

Riva T, Goerge S, Fuchs A, Greif R, Huber M, Lusardi AC, Riedel T, Ulmer FF, Disma N. Emergency front-of-neck access in infants: A pragmatic crossover randomized control trial comparing two approaches on a simulated rabbit model. Paediatr Anaesth. 2024 Mar;34(3):225-234. doi: 10.1111/pan.14796. Epub 2023 Nov 10.

Reference Type: DERIVED

PMID: 37950428 (View on PubMed)

Other Identifiers

Riva-Ulmer2022

Identifier Type: -

Identifier Source: org_study_id