Evaluation of Intubation Rescue Techniques on Management of Difficult Airway

Evaluation of Rescue Techniques After Failed Direct Laryngoscopy: A Multicentered Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Difficult Intubation; Difficult Airway
• Intervention / Treatment: Device: rescue technique

Detailed Description

In anesthesia setting Failed tracheal intubation, leading mortality and morbidity is very important. In operation room when a Difficult intubation occured with concurrent difficult mask ventilation rapid manipulation and quick decision are lifesaving. The Presence of assistant medical personnel or rescue equipment and crisis management of physician is crucial. In anesthesia practice when difficult airway occured rescue techniques are used to facilitate the intubation but difficult airway algorithms do not provide adequate information which rescue technique should be used in a state of emergency in OR thereby current trial was designed to determine which rescue techniques are used in everyday practice to manage difficult intubation, success and complication rates of chosen techniques.

Aim of the study

1. Most preferred rescue technique of the anesthesiologist When a difficult airway or difficult intubation ventilation occured
2. success rate of the chosen technique
3. Incidence of possible complications
4. Most preferred rescue technique of the anesthesiologist on presence of the difficult mask ventilation

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Marmara University School of Medicine
  • Istanbul, Turkey
    • Haydarpasa Numune Researh and Training Hospital
  • Kocaeli, Turkey, 41900
    • Derince Research and Training Hospital
  • Kocaeli, Turkey
    • Kocaeli University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who underwent surgery under general anesthesia over 18 years old

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the success rate of chosen technique for providing an intact airway	Tracheal intubation or supraglottic airway device insertion period will be observed. When end tidal CO2 will be seen on the monitor patient's airway will be accepted as successfully provided. .	Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour
Complications due to intubation	intubation period will be observed and patients will be followed up for complications including throat pain, trauma (pharyngeal, laryngeal, teeth, palate) hypoxemia, death,	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.	The researchers aim to determine the most preferred rescue technique for the anesthesiologists during difficult airway management.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

Collaborators and Investigators

• Sponsor: Derince Training and Research Hospital
• Investigators: Study Director: mehmet yilmaz, Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: difficult intubation; difficult airway; tracheostomy; videolaryngoscope; exchange catheter; fiberoptic bronchoscope; Laryngeal subglottic airway device
• Other Study ID Numbers: DerinceTRH-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No