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

NCT04037553 | Completed

• 1 other identifier: 2019/156
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotracheal Tube Cuff Pressure; Surgery; Ear; Surgery; Head and Neck; Position

Keywords

Endotracheal tube cuff pressure; Ear Surgery; Head and Neck Surgery; Position

Outcome Measures

Primary Outcomes (1)

• Intracuff Pressure

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

  0th minute (just after the positioning from neutral to surgical position)

Secondary Outcomes (5)

• Intracuff Pressure

  15th minute

• Intracuff Pressure

  30th minute

• Intracuff Pressure

  60th minute

• Intracuff Pressure

  90th minute

• Intracuff Pressure

  At the end of the surgery before extubation

Study Arms (3)

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

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

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

Interventions

Intracuff pressure measurement OTHER

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 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective ear or head and neck surgery under general anesthesia.

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, 34104, Turkey (Türkiye)

Location

Related Publications (3)

• American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.

  PMID: 15699079 RESULT

• Lizy C, Swinnen W, Labeau S, Poelaert J, Vogelaers D, Vandewoude K, Dulhunty J, Blot S. Cuff pressure of endotracheal tubes after changes in body position in critically ill patients treated with mechanical ventilation. Am J Crit Care. 2014 Jan;23(1):e1-8. doi: 10.4037/ajcc2014489.

  PMID: 24382623 RESULT

• Komasawa N, Mihara R, Imagawa K, Hattori K, Minami T. Comparison of Pressure Changes by Head and Neck Position between High-Volume Low-Pressure and Taper-Shaped Cuffs: A Randomized Controlled Trial. Biomed Res Int. 2015;2015:386080. doi: 10.1155/2015/386080. Epub 2015 Oct 5.

  PMID: 26509152 RESULT

Study Officials

• Emine A Salviz, MD

  MD, Assoc.Prof.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 30, 2019
• Study Start: February 12, 2019
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

TU (1)