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Videolaryngoscopy During CPR for Trauma Patients

Primary Purpose

Cardiopulmonary Arrest, Neck Injury Multiple

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Endotracheal Intubation

About this trial

This is an interventional treatment trial for Cardiopulmonary Arrest focused on measuring intubation, Cardiopulmonary Resuscitation, neck injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Multiple trauma patients with suspected neck injuries
Arrest Patients

Exclusion Criteria:

Case of requesting the do-not attempt resuscitation before ETI
already intubated case before arrival to hospital
Cardiac arrest from non-traumatic causes

Sites / Locations

Department of Emergency Medicine, Konkuk University Medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

DL user

VL user

Arm Description

Experienced emergency physicians who primarily use the direct laryngoscopy (DL) for endotracheal intubation during cardio-pulmonary resuscitation.

Experienced emergency physicians who primarily use the videolaryngoscopy (VL) for endotracheal intubation during cardio-pulmonary resuscitation.

Outcomes

Primary Outcome Measures

First attempt successful ETI

Successfully insertion of endotracheal tube into trachea at first attempt

Secondary Outcome Measures

the time to complete ETI from the beginning

the time from the advancement of the blade into the patient's mouth to the delivery of the first successful ventilation using the bag

Occurance of complication

Presence of chest compression interruption, esophageal intubation and dental injuries

Full Information

NCT ID

NCT03252886

First Posted

August 14, 2017

Last Updated

December 16, 2017

Sponsor

Konkuk University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03252886

Brief Title

Videolaryngoscopy During CPR for Trauma Patients

Official Title

The Efficacy of Videolaryngoscopy During Cardiac-pulmonary Resuscitation (CPR) for Trauma Patients With Suspect Neck Injuries

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

March 1, 2011 (Actual)

Primary Completion Date

March 1, 2015 (Actual)

Study Completion Date

March 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Konkuk University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a clinical study based on collected video-clip data of cardiopulmonary resuscitation for patients with suspected neck injury in multiple trauma between 2011 and 2015. The study aimed to compare all possible factors relating to ETI performance during CPR for truma patients between experienced video-laryngoscopy and direct- laryngoscopy users.

Detailed Description

Endotracheal intubation (ETI) is considered to be the best method of airway management during cardiopulmonary resuscitation (CPR). However ETI during CPR is a highly skill-dependent procedure, then it should be attempted only highly trained physicians. Especially, cervical immobilization by neck collar in truamatic patients is a great obstacle to successful ETI during CPR. Because of technical difficulty in using direct laryngoscopy (DL), various types of videolaryngoscopy (VL) devices have been developed to overcome the problems of DL. VL may be more useful to perform ETI during CPR for trauma patients with cervical immobilization. This study tried to compare the success rate of endotracheal intubation (ETI), speed of ETI, incidence of complications, and chest compression interruptions during cardiopulmonary resuscitation for trauma patients with suspected neck injury between intubators using the DL and the VL in a real clinical setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiopulmonary Arrest, Neck Injury Multiple

Keywords

intubation, Cardiopulmonary Resuscitation, neck injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DL user

Arm Type

Active Comparator

Arm Description

Experienced emergency physicians who primarily use the direct laryngoscopy (DL) for endotracheal intubation during cardio-pulmonary resuscitation.

Arm Title

VL user

Arm Type

Active Comparator

Arm Description

Experienced emergency physicians who primarily use the videolaryngoscopy (VL) for endotracheal intubation during cardio-pulmonary resuscitation.

Intervention Type

Procedure

Intervention Name(s)

Endotracheal Intubation

Intervention Description

Insertion of endotracheal tube into the trachea and supply oxygen using the Ambu-bagging during cardiopulmonary resuscitation

Primary Outcome Measure Information:

Title

First attempt successful ETI

Description

Successfully insertion of endotracheal tube into trachea at first attempt

Time Frame

within 1 hour after emergency department visit

Secondary Outcome Measure Information:

Title

the time to complete ETI from the beginning

Description

the time from the advancement of the blade into the patient's mouth to the delivery of the first successful ventilation using the bag

Time Frame

within 1 hour after emergency department visit

Title

Occurance of complication

Description

Presence of chest compression interruption, esophageal intubation and dental injuries

Time Frame

within 1 hour after emergency department visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Multiple trauma patients with suspected neck injuries Arrest Patients Exclusion Criteria: Case of requesting the do-not attempt resuscitation before ETI already intubated case before arrival to hospital Cardiac arrest from non-traumatic causes

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang O Park, M.D,Ph.D

Organizational Affiliation

School of Medicine, Konkuk University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Emergency Medicine, Konkuk University Medical center

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Videolaryngoscopy During CPR for Trauma Patients

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