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Trial record 3 of 4872 for:    RESCUE

Evaluation of Intubation Rescue Techniques on Management of Difficult Airway

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03545620
Recruitment Status : Completed
First Posted : June 4, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ayse Zeynep Turan, Derince Training and Research Hospital

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.

Condition or disease Intervention/treatment
Difficult Intubation Difficult Airway 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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 92 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Evaluation of Rescue Techniques After Failed Direct Laryngoscopy: A Multicentered Prospective Observational Study
Actual Study Start Date : December 3, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

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




Primary Outcome Measures :
  1. which rescue technique will be chosen by the anesthesiologist after failed direct laryngoscopy [ Time Frame: Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour ]
    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.


Secondary Outcome Measures :
  1. the success rate of chosen technique for providing an intact airway [ Time Frame: Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour ]
    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. .

  2. Complications due to intubation [ Time Frame: Participants will be followed for the duration of anesthesia and after induction, an expected average of 12 hour ]
    intubation period will be observed and patients will be followed up for complications including throat pain, trauma (pharyngeal, laryngeal, teeth, palate) hypoxemia, death,

  3. Determination of the most preferred rescue technique for the anesthesiologists during difficult airway management. [ Time Frame: Participants will be followed for the duration of anesthesia and after induction, an expected average of 1 hour ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who underwent surgery under general anesthesia over 18 years old
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545620


Locations
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Turkey
Haydarpasa Numune Researh and Training Hospital
Istanbul, Turkey
Marmara University School of Medicine
Istanbul, Turkey
Derince Research and Training Hospital
Kocaeli, Turkey, 41900
Kocaeli University School of Medicine
Kocaeli, Turkey
Sponsors and Collaborators
Derince Training and Research Hospital
Investigators
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Study Director: mehmet yilmaz Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi
Additional Information:

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Responsible Party: Ayse Zeynep Turan, Principle Investigator, Derince Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03545620    
Other Study ID Numbers: DerinceTRH-04
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayse Zeynep Turan, Derince Training and Research Hospital:
difficult airway
difficult intubation
videolaryngoscope
exchange catheter
fiberoptic bronchoscope
Laryngeal subglottic airway device
tracheostomy