NCT03545620

Brief Summary

When difficult airway/intubation occurs in the OR the anesthesiologist needs rescue techniques and equipment. The algorithms about management of the difficult airway don't provide adequate data. In current study researchers aim to determine most preferred rescue techniques and success rate of the chosen technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

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

December 3, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

April 18, 2018

Last Update Submit

June 20, 2018

Conditions

Keywords

difficult airwaydifficult intubationvideolaryngoscopeexchange catheterfiberoptic bronchoscopeLaryngeal subglottic airway devicetracheostomy

Outcome Measures

Primary Outcomes (1)

  • which rescue technique will be chosen by the anesthesiologist after failed direct laryngoscopy

    In case of a difficult airway situation after anesthesia induction patients will be enrolled to the study. Researchers will observe the case and record the chosen rescue technique such as video laryngoscope, supraglottic airway device, fiberoptic intubation or tracheostomy. Here the researchers aim to observe the preferred rescue method of providing an intact airway.

    Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour

Secondary Outcomes (3)

  • the success rate of chosen technique for providing an intact airway

    Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour

  • Complications due to intubation

    Participants will be followed for the duration of anesthesia and after induction, an expected average of 12 hour

  • Determination of the most preferred rescue technique for the anesthesiologists during difficult airway management.

    Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour

Study Arms (1)

Difficult intubation,

Patients who underwent surgery under general anesthesia will be follow up. Patients predicted difficult intubation/airway or established difficult intubation/airway after anesthesia induction will be included. Which rescue technique will be used after unsuccessful direct laryngoscopy will be recorded.

Device: rescue technique

Interventions

which rescue technique will be preferred while established/predicted difficult airway/intubation occurs in the operation room after failed direct laryngoscopy

Difficult intubation,

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent surgery under general anesthesia over 18 years old

You may qualify if:

  • aged over 18 years
  • patient underwent surgery under general anesthesia

You may not qualify if:

  • pediatric patients
  • patients who will intubate due to rapid serial intubation protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Haydarpasa Numune Researh and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Derince Research and Training Hospital

Kocaeli, 41900, Turkey (Türkiye)

Location

Kocaeli University School of Medicine

Kocaeli, Turkey (Türkiye)

Location

Study Officials

  • mehmet yilmaz

    Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 18, 2018

First Posted

June 4, 2018

Study Start

December 3, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 21, 2018

Record last verified: 2018-06

Locations