Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Video and Traditional Laryngoscopy on Hemodynamic Response in Hypertensive and Normotensive Patients (Laryngoscopy)

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: NCT03376828
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : December 26, 2018
Sponsor:
Information provided by (Responsible Party):
SİNAN YILMAZ, Aydin Adnan Menderes University

Brief Summary:
During endotracheal intubation, it is known that la laryngoscopy has significant effects, such as tachycardia and blood pressure increase, which may be harmful, especially in those with cardiovascular disease. Different studies comparing laryngeal stimulation and there resulting hemodynamic response made with various intubation devices are available in the literature. The investigators planned to work with the hypothesis that endotracheal intubation with videolaryngoscopy would have less hemodynamic response traditional (Macintosh) laryngoscopy and the use of videolaryngoscopy would result in wider vision with less laryngeal stimulation.

Condition or disease Intervention/treatment Phase
Intubation Anesthesia Hypertension Device: Macintosh laryngoscopy Device: C-Mac Videolaryngoscope Not Applicable

Detailed Description:

In this study, in a study on endotracheal intubation under general anesthesia, a routine preparation of endotracheal intubation using video laryngoscopy or Macintosh laryngoscopy in adult hypertensive and normotensive patients between 18-75 years old, form will be written and recorded.

Patient age, weight, height, sex, operation, co-morbid conditions and vital findings, measurements used in airway evaluation, initial trial success, laryngoscope using number of procedures, intubation tube number will be recorded.

Statistical analysis was performed using statistical program to compare the hemodynamic response of hypertensive and normotensive patients using videolaryngoscope or Macintosh laryngoscope

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prospective
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Video and Traditional Laryngoscopy on Hemodynamic Response in Hypertensive and Normotensive Patients
Actual Study Start Date : May 25, 2016
Actual Primary Completion Date : May 25, 2018
Actual Study Completion Date : May 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hypertensive T group
Hypertensive T group: Patients participating in the study were randomly assigned hypertensive (preoperative systolic blood pressure <180 mmHg and diastolic blood pressure <100 mmHg) Macintosh laryngoscopy using intubated
Device: Macintosh laryngoscopy
Endotracheal intubation time using the Macintosh laryngoscope

Active Comparator: Hypertensive VL group
Hypertensive VL group: Patients participating in the study were randomly assigned hypertensive (preoperative systolic blood pressure <180 mmHg and diastolic blood pressure <100 mmHg) C-Mac Videolaryngoscope using intubated
Device: C-Mac Videolaryngoscope
Endotracheal intubation time using the C-Mac Videolaryngoscope

Sham Comparator: Non-hypertensive T group
Non-hypertensive T group: (Preoperative systolic blood pressure < 140 mmHg and diastolic blood pressure < 100 mmHg) Macintosh laryngoscopy using intubated
Device: Macintosh laryngoscopy
Endotracheal intubation time using the Macintosh laryngoscope

Sham Comparator: Non-hypertensive VL group
Non-hypertensive VL group: Preoperative systolic blood pressure < 140 mmHg and diastolic blood pressure < 100 mmHg C-Mac Videolaryngoscope using intubated
Device: C-Mac Videolaryngoscope
Endotracheal intubation time using the C-Mac Videolaryngoscope




Primary Outcome Measures :
  1. Hemodynamic response [ Time Frame: 0-10 minute ]
    Change from baseline noninvasive blood pressure and heart rate


Secondary Outcome Measures :
  1. intubation time [ Time Frame: 0-120 seconds ]
    The time elapsed between the passage of the laryngoscopy through the teeth to teeth

  2. Glottic view grade [ Time Frame: During intubation ]
    Using the Cormack Lehane score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 18-75 years.
  • Underwent surgery under general anesthesia.

Exclusion Criteria:

  • ASA (American Society of Anesthesiologists) IV, V patients
  • Preoperative systolic blood pressure 180 mmHg, diastolic blood pressure a pressure above 110 mmHg.
  • Ejection fraction is less than 40%.
  • Difficult intubation history
  • Mallampati 3,4

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): NCT03376828


Locations
Layout table for location information
Turkey
Adnan Menderes University Training and Research Hospital
Aydın, Turkey, 09100
Sponsors and Collaborators
Aydin Adnan Menderes University
Publications:
Layout table for additonal information
Responsible Party: SİNAN YILMAZ, Principal Investigator, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03376828    
Other Study ID Numbers: 2016/855
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 26, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by SİNAN YILMAZ, Aydin Adnan Menderes University:
laryngoscopy
videolaryngoscopy
hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases