Evaluation of Intubation Rescue Techniques on Management of Difficult Airway

Difficult Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545620
• Other study ID #: DerinceTRH-04
• Status: Completed
• Start date: December 3, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2018
• Source: Derince Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Difficult Airway
• Difficult Intubation

Intervention

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

Locations

Country	Name	City	State
Turkey	Haydarpasa Numune Researh and Training Hospital	Istanbul
Turkey	Marmara University School of Medicine	Istanbul
Turkey	Derince Research and Training Hospital	Kocaeli
Turkey	Kocaeli University School of Medicine	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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