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Changes of Endotracheal Tube Cuff Pressures After Ear, Head and Neck Surgery Positions

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: NCT04037553
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Emine Aysu Salviz, MD, Istanbul University

Brief Summary:

Increased or decreased intracuff pressures (ICPs) of cuffed endotracheal tubes (cETTs) can lead to many morbidities.The ICPs of cETTs can be changed by the the patients' ear and head&neck surgery positions. We performed this study to show the effect of the routine combination of neck positions on ICP whilst ear and head& neck surgeries.

A total of 90 patients were enrolled to the study. Groups 1 and 2 included the patients who underwent right and left ear surgeries, respectively. Group 3 included all patients undergoing head and neck surgery.After the general anesthesia induction, the patients were given a neutral position.The first ICP was measured and adjusted to 18,4 mm Hg (25 cmH2O) at neutral position. Left or right neck rotation was applied to Group 1 or 2 in conformity with the ear operation site and ICP value was documented. Gel pillow with the height of 4,5 cm was placed under the shoulders of Group 3 patients to extend the neck and the ICP was noted. Then, right or left neck rotation was applied depending on the operation side and ICP was documented again. Additionally, ICP values were monitorized continuously in all patients during the surgeries, and documented at 15th, 30th, 60th and 90th minutes at related positions and just before extubation at neutral position. If the ICP value fell below 14,7 mmHg (20 cmH2O) or rose above 22 mmHg (30 cmH2O), ICP was adjusted to 18,4 mm Hg (25 cmH2O) again.


Condition or disease Intervention/treatment
Endotracheal Tube Cuff Pressure Surgery; Ear Surgery; Head and Neck Position Other: Intracuff pressure measurement

Detailed Description:

Increased or decreased intracuff pressures (ICPs) of cuffed endotracheal tubes (cETTs) can lead to many morbidities. Guidelines recommend that the ICP should be kept between 20 and 30 cmH2O. Over inflation of the cuff can cause tracheal mucosal injury ,tracheal stenosis, tracheoesophageal fistula, postoperative stridor, laryngospasm, laryngeal nerve damage and tracheal rupture. However, under inflation can cause air leakage, aspiration and ventilation associated pneumonia.The cETT can be displaced by movement of the patients' heads and necks while positioning for surgeries of ear, head and neck. These positionings and displacements may be the reasons of changes in ICPs. The investigators performed this study to show the effect of the routine combination of neck positions on ICP whilst ear, head and neck surgeries.

After obtaining ethics committee approval and written informed consent, 90 patients with American Society of Anesthesiologists (ASA) physical status I-III and aged older than 18 years were enrolled to the study. The patients were allocated to 3 groups according to their surgery types. Groups 1 and 2 included the patients who underwent right and left ear surgeries, respectively. Group 3 included all patients undergoing head and neck surgery without considering the surgical site. After the general anesthesia induction, the patients were given a neutral position defined by Komasawa et al. The first ICP was measured and adjusted to 18,4 mm Hg (25 cmH2O) at neutral position just after taping the tube and monitoring the 3 consecutive respiration cycles. After neutral measurements, left or right neck rotation (approximately 60-70 degree to the opposite site) was applied to Group 1 or 2 in conformity with the ear operation site and ICP value was documented following 3 respiration cycles. Gel pillow with the height of 4,5 cm was placed under the shoulders of Group 3 patients to extend the neck. After waiting for 3 respiration cycles, the ICP was noted. Then, right or left neck rotation was applied depending on the operation site (approximately 60-70 degree to the opposite site). Following 3 respiration cycles, ICP was documented again. Additionally, ICP values were monitorized continuously in all patients during the surgeries, and documented at 15th, 30th, 60th and 90th minutes at related positions and just before extubation at neutral position. At any time point, if ICP value fell below 14,7 mmHg (20 cmH2O) or rose above 22 mmHg (30 cmH2O), ICP was adjusted to 18,4 mm Hg (25 cmH2O) again. After all data were collected, statistical analysis were performed by using Statistical Package for the Social Sciences (SPSS) version 22.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: The Changes of Endotracheal Tube Cuff Pressures After Ear, Head and Neck Surgery-Related Positions: A Prospective Observational Study
Actual Study Start Date : February 12, 2019
Actual Primary Completion Date : May 10, 2019
Actual Study Completion Date : May 10, 2019

Group/Cohort Intervention/treatment
Group 1
Patients underwent right ear surgery: After intracuff pressure (ICP) is adjusted to 25 cmH2O at neutral position, lateral neck rotation (approximately 60-70 degrees to the left) was applied to the patients and ICP values were documented following 3 respiration cycles.
Other: Intracuff pressure measurement
Intracuff pressure values were monitorized and noted before and after head and neck positions and during the surgeries at 15th, 30th, 60th and 90th minutes at related positions and just before extubation at neutral position.

Group 2
Patients underwent left ear surgery: After intracuff pressure (ICP) is adjusted to 25 cmH2O at neutral position, lateral neck rotation (approximately 60-70 degrees to the right) was applied to the patients and ICP values were documented following 3 respiration cycles.
Other: Intracuff pressure measurement
Intracuff pressure values were monitorized and noted before and after head and neck positions and during the surgeries at 15th, 30th, 60th and 90th minutes at related positions and just before extubation at neutral position.

Group 3
Patients underwent left head and neck surgery: After intracuff pressure (ICP) is adjusted to 25 cmH2O at neutral position, gel pillow with the height of 4,5 cm was placed under the shoulders of patients to extend the neck. Following 3 respiration cycles, the ICPs were noted. Then, right or left lateral neck rotation was applied depending on the operation side (approximately 60-70 degree to the opposite site). After 3 respiration cycles, ICPs were documented again.
Other: Intracuff pressure measurement
Intracuff pressure values were monitorized and noted before and after head and neck positions and during the surgeries at 15th, 30th, 60th and 90th minutes at related positions and just before extubation at neutral position.




Primary Outcome Measures :
  1. Intracuff Pressure [ Time Frame: 0th minute (just after the positioning from neutral to surgical position) ]
    Endotracheal Tube Cuff Pressures After Ear, Head and Neck Surgery Positions


Secondary Outcome Measures :
  1. Intracuff Pressure [ Time Frame: 15th minute ]
    Endotracheal Tube Cuff Pressure at 15th minute at surgery-related position

  2. Intracuff Pressure [ Time Frame: 30th minute ]
    Endotracheal Tube Cuff Pressure at 30th min at surgery-related position

  3. Intracuff Pressure [ Time Frame: 60th minute ]
    Endotracheal Tube Cuff Pressure at 60th min at surgery-related position

  4. Intracuff Pressure [ Time Frame: 90th minute ]
    Endotracheal Tube Cuff Pressure at 90th min at surgery-related position

  5. Intracuff Pressure [ Time Frame: At the end of the surgery before extubation ]
    Endotracheal Tube Cuff Pressure just before extubation at neutral position



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for elective ear or head and neck surgery under general anesthesia.
Criteria

Inclusion Criteria:

  • > 18 years old
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Patients who scheduled for elective ear or head and neck surgery under general anesthesia

Exclusion Criteria:

  • Morbid obesity (body mass index (BMI) >35)
  • Limited neck movements
  • Previous history of radiotherapy or surgery to the head and neck area
  • Nasotracheal intubation under general anesthesia
  • Peroperative tracheotomy requirements
  • Respiratory tract infection
  • Surgery planned for midline neck masses

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): NCT04037553


Locations
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Turkey
Istanbul University
Istanbul, Turkey, 34104
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Emine A Salviz, MD MD, Assoc.Prof.
Publications of Results:
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Responsible Party: Emine Aysu Salviz, MD, Associate Professor, Istanbul University
ClinicalTrials.gov Identifier: NCT04037553    
Other Study ID Numbers: 2019/156
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Emine Aysu Salviz, MD, Istanbul University:
Endotracheal tube cuff pressure
Ear Surgery
Head and Neck Surgery
Position