NCT06542406

Brief Summary

Endotracheal intubation (ETE) may also need to be performed outside the hospital as advanced airway management. In such cases, facilities such as imaging methods, ultrasound or capnography may not be available and only traditional methods such as auscultation of lung sounds, auscultation of the epigastric region without hearing airflow, observation of chest expansion after ventilation, observation of water vapor in the tube may have to be used. Despite all these observational methods and equipment used, it is recommended to keep in mind that there may be errors and to try to provide confirmation with more than one method. Especially in disaster situations where technological infrastructure is not available and sometimes outside the hospital, the use of traditional methods based on examination may be of vital importance. The traditional methods mentioned above are mostly used to detect tracheal localization and to exclude esophageal localization. In our observations in patients with cardiopulmonary arrest, the investigators noticed that in the case of esophageal placement of the tube, manual compression of the epigastric region produced a fluctuation in the tube and valved balloon caused by airflow. The investigators thought that this could be a method to confirm esophageal placement. The aim of this study was to investigate the usefulness of epigastric manual compression in the confirmation of esophageal placement of the tube.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

July 26, 2024

Last Update Submit

August 4, 2024

Conditions

Keywords

endotracheal intubationesophageal placementepigastric fluctuation

Outcome Measures

Primary Outcomes (1)

  • Confirmation with ultrasonography: Successful or Failed

    Fluctuation with Epigastric Compression: Yes or No Failed Successful Failed

    13 months

Study Arms (1)

Endotracheal intubation

OTHER

Patients admitted to the emergency department between 01/05/2021 and 30/05/2022, who were older than 18 years of age and who underwent ETE outside the hospital or within the first hour of arrival to the emergency department were included in the study.

Device: Endotracheal intubation

Interventions

The first 40 successful and the first 40 unsuccessful ETE procedures were included in the study.

Endotracheal intubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years of age
  • Underwent ETE outside the hospital or within the first hour of arrival to the emergency department

You may not qualify if:

  • Patients in whom ETE was previously confirmed by USG or PETCO2,
  • Patients intubated at external centers
  • Patients who had known airway stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duzce University

Düzce, Turkey (Türkiye)

Location

Related Publications (3)

  • Farrokhi M, Yarmohammadi B, Mangouri A, Hekmatnia Y, Bahramvand Y, Kiani M, Nasrollahi E, Nazari-Sabet M, Manoochehri-Arash N, Khurshid M, Mosalanejad S, Hajizadeh V, Amani-Beni R, Moallem M, Farahmandsadr M. Screening Performance Characteristics of Ultrasonography in Confirmation of Endotracheal Intubation; a Systematic Review and Meta-analysis. Arch Acad Emerg Med. 2021 Oct 26;9(1):e68. doi: 10.22037/aaem.v9i1.1360. eCollection 2021.

  • Li X, Zhang J, Karunakaran M, Hariharan VS. Diagnostic accuracy of ultrasonography for the confirmation of endotracheal tube intubation: a systematic review and meta-analysis. Med Ultrason. 2023 Mar 30;25(1):72-81. doi: 10.11152/mu-3594. Epub 2022 Jun 3.

  • Kramer-Johansen J, Dorph E, Steen PA. Detection of carbon dioxide in expired air after oesophageal intubation; the role of bystander mouth-to-mouth ventilation. Acta Anaesthesiol Scand. 2008 Jan;52(1):155-7. doi: 10.1111/j.1399-6576.2007.01503.x. Epub 2007 Nov 12.

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Mustafa Boğan, MD

    Duzce University, School of Medicine, Emergency Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher Assistant in Emergency Department

Study Record Dates

First Submitted

July 26, 2024

First Posted

August 7, 2024

Study Start

February 18, 2021

Primary Completion

March 4, 2023

Study Completion

March 4, 2023

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Data can be shared with those who request it.

Locations