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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03826706
Other study ID # Asozkan 4
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 15, 2019
Est. completion date April 10, 2019

Study information

Verified date February 2019
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation with double lumen tube. The use of Storz C-MAC D Blade and McGrath MAC X3 Blade videolaryngoscope were compared in intubation of single lung ventilation patients who underwent chest surgery in terms of duration of intubation, hemodynamic response and intubation-induced complications.


Description:

It is very important for anesthesiologists to evaluate and make the airway safe in order to start and continue surgical operations. Endotracheal intubation has many important reasons such as ensuring airway control safely during surgical procedure, increasing the depth of anesthesia, need interventions for surgical or anesthetic complications, reduction of dead space, reduction of respiratory effort and prevention of aspiration risk. Videolaryngoscope, developed in recent years and beginning to take place in the algorithms, facilitate difficult airway management and hence intubation.

The use of videolaryngoscope in patients with intubation such as double lumen tube, has been frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better quality video and camera system and improves the performance of videolaryngoscope with some technological changes. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope with D blade and McGrath MAC videolaryngoscope with X3 blade in respect to duration of intubation, haemodynamic response, and adverse events associated with intubation of patients undergoing lung surgery.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date April 10, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiology score III,

- 18-65 years,

- BMI> 40

- Patients who was intubated with double lumen tube.

Exclusion Criteria:

- American Society of Anesthesiology IV,

- Under 18 years,

- Over 65 years,

- Under BMI<40

- Obstetric patients,

- Uncontrolled cerebrovascular disease,

- Patients who refused written informed consent forms

Study Design


Related Conditions & MeSH terms


Intervention

Device:
C-MAC Videolaryngoscope D blade
C-MAC videolaryngoscope D blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.
McGrath MAC Videolaryngoscope X3 blade
McGrath MAC videolaryngoscope X blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.

Locations

Country Name City State
Turkey Ahmet Selim Ozkan Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to intubation Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Secondary Heart Rate Heart Rate From beginning of Anesthesia induction to 5th minutes of intubation
Secondary Mean Arterial Pressure Mean Arterial Pressure At beginning of Anesthesia induction, 1st, 2nd, 3th and 5th minutes of intubation
Secondary Adverse Events Bleeding in the mouth, edema in the mouth, burst of intubation tube cuff, external laryngeal press, presence of head position change, laryngospasm, hypoxia, hoarseness, throat ache During the first 24 hour postoperatively
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