Dysphagia Clinical Trial
Official title:
The Effect of Cold Vapor on Intubation-Related Symptoms and Comfort in the Early Postoperative Period
Endotracheal Intubation (EI) is performed in order to monitor the effectiveness of anesthesia and to control the patient's breathing during the surgery under general anesthesia. In EI, which is an invasive procedure, damage to the larynx and trachea may occur during the placement of the endotracheal tube or due to long-term use. Complications such as postintubation ulcer, laryngeal nerve paresis, arytenoid dislocation may develop in the early period due to EI, and patients may have complaints such as sore throat, swallowing problems, hoarseness, and cough in the postoperative period. This affects the comfort of the patients in the postoperative period. For this reason, it is important to prevent intubation-related symptoms of patients who will undergo surgical intervention before they occur.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | November 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Being 18 years or older - Having an ASA score of 1-2 - Not having any respiratory problems before the operation - Not having a neurological disease related to swallowing - Not having a sore throat due to cancer and chronic diseases - Not having hoarseness before surgery - With endotracheal intubation, the duration of the operation is at least 60 minutes under general anesthesia. - Having surgery in one of the prone and supine positions - Getting 2 points from the Ramsay Sedation Scale in the postoperative recovery room. - Having a Modified Aldrete score of at least 9 in the postoperative recovery room - To be willing to participate in the study. Exclusion Criteria: - To undergo emergency surgery - Being under the age of 18 - Having an ASA score of 3 and above - Having any respiratory problems in the preoperative period - Having a neurological disease related to swallowing - Having a sore throat due to cancer and chronic diseases - Having throat surgery - The duration of the operation is less than 60 minutes - Having surgery in a position other than the prone and supine positions - Not agreeing to participate in the study. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Istanbul Medeniyet University | Maltepe University |
Bulut H, Erden S, Demir SG, Çakar B, Erdogan Z, Demir N, Ay A, Aydin E. The Effect of Cold Vapor Applied for Sore Throat in the Early Postoperative Period. J Perianesth Nurs. 2016 Aug;31(4):291-7. doi: 10.1016/j.jopan.2014.10.005. Epub 2016 Feb 24. — View Citation
Chang JE, Min SW, Kim CS, Han SH, Kwon YS, Hwang JY. Effect of prophylactic benzydamine hydrochloride on postoperative sore throat and hoarseness after tracheal intubation using a double-lumen endobronchial tube: a randomized controlled trial. Can J Anaesth. 2015 Oct;62(10):1097-103. doi: 10.1007/s12630-015-0432-x. Epub 2015 Jul 7. — View Citation
Jung TH, Rho JH, Hwang JH, Lee JH, Cha SC, Woo SC. The effect of the humidifier on sore throat and cough after thyroidectomy. Korean J Anesthesiol. 2011 Dec;61(6):470-4. doi: 10.4097/kjae.2011.61.6.470. Epub 2011 Dec 20. — View Citation
Kim D, Jeon B, Son JS, Lee JR, Ko S, Lim H. The changes of endotracheal tube cuff pressure by the position changes from supine to prone and the flexion and extension of head. Korean J Anesthesiol. 2015 Feb;68(1):27-31. doi: 10.4097/kjae.2015.68.1.27. Epub 2015 Jan 28. — View Citation
Kim D, Jeong H, Kwon J, Kang S, Han B, Lee EK, Lee SM, Choi JW. The effect of benzydamine hydrochloride on preventing postoperative sore throat after total thyroidectomy: a randomized-controlled trial. Can J Anaesth. 2019 Aug;66(8):934-942. doi: 10.1007/s12630-019-01371-2. Epub 2019 Apr 16. — View 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. — View Citation
Paltura C, Güvenç A, Develioglu ÖN, Yelken K, Külekçi M. Original Research: Aerosolized Lidocaine: Effective for Safer Arousal After Suspension Laryngoscopy. J Voice. 2020 Jan;34(1):130-133. doi: 10.1016/j.jvoice.2018.08.012. Epub 2018 Sep 15. — View Citation
Sahbaz M, Khorshid L. The Effect of Cold Vapor and Ice Cube Absorption in the Early Postoperative Period on Sore Throat and Hoarseness Induced by Intubation. J Perianesth Nurs. 2020 Oct;35(5):518-524. doi: 10.1016/j.jopan.2019.12.007. Epub 2020 May 10. — View Citation
Stout DM, Bishop MJ, Dwersteg JF, Cullen BF. Correlation of endotracheal tube size with sore throat and hoarseness following general anesthesia. Anesthesiology. 1987 Sep;67(3):419-21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cold vapor | The sore throat, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 10 is taken from the Visual Analogue Scale (VAS). It is good that the score on the scales has decreased. | First 24 hours after surgery | |
Primary | Cold vapor | The cough, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 4 is taken from the Cough Severity Form (CSF). It is good that the score on the scales has decreased. | First 24 hours after surgery | |
Primary | Cold vapor | Swallowing, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 24 is taken from the Swallowing Impairment Score (SIS). It is good that the score on the scales has decreased. | First 24 hours after surgery | |
Primary | Cold vapor | The hoarseness, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 3 is taken from the Shout's Hoarseness Scale (SHS). It is good that the score on the scales has decreased. | First 24 hours after surgery | |
Primary | Cold vapor | The Perianesthesia Comfort Scale (PCS) of the patients for comfort who underwent cold vapor is decreased compared to those who do not. A score between 24 and 144 is taken from the PCS. It is good that the score from the PCS has increased. | 24th hour after surgery |
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