Clinical Trial: Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients
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.
Detailed Summary:
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. It would seem ideal to be able to unify both techniques in one single device; in other words, 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.
LOCATION: The study will be conducted at operating rooms serving inpatients at the Valencia Clinical University Hospital. Investigators will be anesthesiologists with long experience in fibroscopy and in the management of supraglottic devices used for intubation.
METHODOLOGY: Prospective observational study aimed at evaluating the success of intubation through an I-LTSD device in regular clinical practice.
Research 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. All patients will be required to sign an informed consent form.
Study variables: Information on the following variables will be gathered:
- Demographic variables: age, gender, weight, height
- Clinical variables: American Society Anaesth
Sponsor: Formacion Internacional para la Docencia e Investigación de la Vía Aérea
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Formacion Internacional para la Docencia e Investigación de la Vía Aérea
Dates:
Date Received: May 21, 2017
Date Started: June 1, 2017
Date Completion: September 30, 2017
Last Updated: May 22, 2017
Last Verified: May 2017
