Evaluation of Complications in Airway Management (AMC)

July 10, 2018 updated by: Ayse Zeynep Turan, Derince Training and Research Hospital

Evaluation of Complications During Airway Management: An Observational Prospective Cohort Study

In the current study researchers aim to evaluate the rate of the complication due to airway management (during intubation or placement of supraglottic airway devices)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Airway management is one of the most important subject of anesthesia practice. Airway devices ,helping anesthesiologists to maintain airway safety have many complications. 4 th national audit project (NAP 4) study was designed to evaluate the incidence of the major complication of airway management. Accordingly in current study authors aim to determine the complications and incidence of the complications during airway management.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41900
        • Derince Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who undergo surgery under general anesthesia and who intubate/place supraglottic airway device will be recruit for study over a period of six months

Description

Inclusion Criteria:

  • Patients undergoing general anesthesia
  • Patients to whom airway devices will be inserted

Exclusion Criteria:

  • Patients who undergo surgery under regional anesthesia
  • Patients who undergo surgery under sedation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
general anesthesia
Patients who undergo general anesthesia and are intubated or inserted airway device will be enrolled. researchers will follow the induction and intubation period and record all the complications due to airway management.
Procedure: airway management
patients will be intubated or will be placed an airway device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of the complications due to airway management
Time Frame: 6 months
researchers will observe the whole patients who undergo general anesthesia and record the data
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
variety of complications and reasons of the complications
Time Frame: 6 months
researchers will observe the whole patients who undergo general anesthesia and record the data
6 months
preventable reasons of the complications
Time Frame: 6 months
researchers will observe the whole patients who undergo general anesthesia and record the data
6 months
the time at which complications occurs more, during airway management
Time Frame: 6 months
researchers will observe the whole patients who undergo general anesthesia and record the data
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derince Training and Research Hospital

Investigators

  • Study Director: tolga k saracoglu, assoc. prof., Sağlık Bilimleri Üniversitesi Kocaeli Derince SUAM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

May 27, 2018

First Submitted That Met QC Criteria

May 27, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DerinceTRH-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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