Clinical trial NCT04037553: Changes of Endotracheal Tube Cuff Pressures After Ear, Head and Neck Surgery Positions
Official title: The Changes of Endotracheal Tube Cuff Pressures After Ear, Head and Neck Surgery-Related Positions: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Tube Cuff Pressure
Surgery; Ear
Surgery; Head and Neck
Position
Keywords: Endotracheal tube cuff pressure
Ear Surgery
Head and Neck Surgery
Position
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective ear or head and neck surgery under general anesthesia.

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.

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.

Eligibility 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

Primary outcomes:
measure: Intracuff Pressure
timeFrame: 0th minute (just after the positioning from neutral to surgical position)
Secondary outcomes:
measure: Intracuff Pressure
timeFrame: 15th minute
measure: Intracuff Pressure
timeFrame: 30th minute
measure: Intracuff Pressure
timeFrame: 60th minute
measure: Intracuff Pressure
timeFrame: 90th minute
measure: Intracuff Pressure
timeFrame: At the end of the surgery before extubation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: MD, Assoc.Prof.
name: Emine A Salviz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.