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Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients (IKING)

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ClinicalTrials.gov Identifier: NCT03165461
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
pedro charco mora, Formacion Internacional para la Docencia e Investigación de la Vía Aérea

Brief Summary:

Failed intubation is currently one of the most important factors leading to morbidity and mortality in anesthesia.

The development of supraglottic airway devices (SGDs), such as the intubating laryngeal tube, has revolutionized airway management, as these devices allow adequate ventilation and oxygenation in situations where ventilation and/or intubation via conventional means pose a challenge. Several publications describe the usefulness of such devices for salvaging ventilation in patients that cannot be intubated with direct laryngoscopy or who cannot be ventilated with a facemask. In these salvage situations, SGDs are highly effective in achieving adequate patient oxygenation.

Achieving effective oxygenation with an SGD and completely isolating the airway by intubation at the same time. This is now possible thanks to the so called supraglottic intubation devices (SGIDs). For that reason, we believe it is necessary to conduct a study that allows evaluation of the performance of this device in the context of daily clinical practice.

Its design characteristics, its capacity to be used in intubation applications, its soft and atraumatic materials as well as its disposability augur this product a significant expansion in the next few years. Nonetheless, no data are available on the success of intubation when the intubating laryngeal tube suction device (ILTSD) is used. The idea behind this study is to assess the possibilities to use the ITLSD device to intubate patients in regular anesthetic practice.


Condition or disease
Airway Obstruction Difficult Intubation

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients
Actual Study Start Date : May 26, 2017
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : September 30, 2017



Primary Outcome Measures :
  1. To evaluate success of fiberoptic guide endotraqueal intubation through an I-LTSD device in patients to general anesthesia without difficult intubation. [ Time Frame: one day ]

    The study will determinate the success of visual fiberoptic intubation at a first and a second attempt and guided fiberoptic intubation at a third and last attempt. Should the third attempt fail, intubation will be performed through direct or indirect laryngoscopy.

    The initial success rate will be calculated and the number of attempts needed for successful intubation will be recorded.




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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:   Probability Sample
Study Population

The study population will be made up of adult patients undergoing elective surgery who require general anesthesia and endotracheal intubation. Patients will be included in a consecutive manner provided that selection criteria are met, then patients will be informed about the study and they will be invited to participate. If they agree, they will be asked to sign an informed consent form either in the pre-anesthesia unit or in the ward. This must be done well before the patient is taken to the operating room.

All patients will be required to sign an informed consent form.

Criteria

Inclusion Criteria:

  • ASA I, II & III.
  • Age over 18.
  • Outpatient and inpatient surgery requiring endotracheal intubation. Signature of an informed consent form.

Exclusion Criteria:

  • Patients who, on initial airway examination, exhibit any of the following conditions associated with a difficult airway: cervical spine pathology, mouth opening restriction of less than 3 cm. (combination of Mallampati class III-IV, thyromental distance < 6 cm and reduced mouth opening).
  • A history of severe gastroesophagic reflux and/or a history of recent respiratory infection.
  • Refusal of the patient to participate in the study.

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): NCT03165461


Locations
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Spain
Pedro Charco Mora
Valencia, Spain, 46002
Sponsors and Collaborators
Formacion Internacional para la Docencia e Investigación de la Vía Aérea
Investigators
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Study Chair: pedro Charco-Mora, MD, PhD Formacion Internacional para la Docencia e Investigación de la Vía Aérea
Publications of Results:
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Responsible Party: pedro charco mora, Director, Formacion Internacional para la Docencia e Investigación de la Vía Aérea
ClinicalTrials.gov Identifier: NCT03165461    
Other Study ID Numbers: HCV2017LT
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by pedro charco mora, Formacion Internacional para la Docencia e Investigación de la Vía Aérea:
intubation to supraglottic devices
intubating laryngeal tube
Additional relevant MeSH terms:
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Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases