The Effect of Cold Vapor on Intubation-Related Symptoms and Comfort in the Early Postoperative Period

Dysphagia Clinical Trial

Official title:

The Effect of Cold Vapor on Intubation-Related Symptoms and Comfort in the Early Postoperative Period

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05317156
• Other study ID #: IstanbulMU13
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2022
• Source: Istanbul Medeniyet University
• Contact: Özlem Ibrahimoglu, PhD
• Phone: +905436195971
• Email: oogutlu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. In addition, similar complaints may be encountered after extubation due to the displacement of the cuff of the EI and changes in the cuff pressure during the head and body positioning of the patient for surgical intervention after the EI. In the literature, studies examining the effect of intraoperative patient position on symptoms associated with postoperative intubation are limited. Baran Akkuş and Çaparlar (2020) evaluated the postoperative period of sore throat, hoarseness, dysphagia, and cough by controlling the cuff pressure in patients with hyperextension and supine position, and they did not find a significant difference between the groups. Although the severity of intubation-related complaints, which usually regress within 24 to 72 hours in the postoperative period, varies from patient to patient, it can affect the comfort of the patients in the early postoperative period.

In the literature, there are many studies conducted to relieve the symptoms of sore throat, cough, hoarseness, and dysphagia in patients after extubation. In these studies, pharmacological analgesic agents such as nonsteroidal anti-inflammatory drugs, steroids, opioids, local anesthetics; different anesthetic techniques, the use of different sized endotracheal tubes, intubation after complete muscle relaxation, minimizing cuff pressure, and lubricating gels such as local anesthetics or oral lozenges, sprays and mouthwash solutions are used around or inside the intubation tube cuff. There are many studies in the literature on the successful application of non-pharmacological agents in the treatment of pain. Patients with post-operative throat complaints are recommended to take warm liquids, avoid solid food, suck ice chips, use lozenges, and apply steam. The cold application creates vasoconstriction in the vessels in the area where it is applied, decreases the metabolic rate, and reduces edema. The cold application reduces muscle temperature by reducing the tension sensitivity of muscle spindles with the reflex effect of heat receptors or by inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it reduces skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially beneficial in post-traumatic pain, swelling, and muscle spasm. 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. Although it is seen in the literature that pharmacological, non-pharmacological, and herbal methods are applied to reduce postoperative sore throat, cough, hoarseness, and dysphagia, no study has been found examining the effect of the cold steam application on symptoms associated with IE.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cold
• Cough
• Dysphagia
• Hoarseness
• Intubation Complication
• Pharyngitis
• Sore Throat

Intervention

Other:
• Cold vapor
Before surgery, the socio-demographic data of the patients will be recorded. After surgery, patients will be evaluated in the recovery room for their suitability to participate in the study with the Ramsay sedation scale and the Modified Aldrete Scale. Cold vapor will be applied to the patients for 15 minutes in the recovery room during the postoperative period. The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5, air blowing intensity 5, heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of sore throat, cough, hoarseness, and dysphagia before and 15 minutes after the cold vapor application in the recovery room and at the 6th,12th, and 24th hours after the cold vapor application in the postoperative service. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Medeniyet University	Maltepe University

References & Publications (9)

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

Outcome

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

External Links

•   AKKUS, I. B., & ÇAPARLAR, C. Ö. (2020). Basin Hiperekstansiyonu Endotrakeal Kaf Basincini Etkiler mi?. Turkiye Klinikleri J Anest Reanim, 18(1), 1-7.
•   Ghaleb, M. A., Falatah, S., & Al-Amoudi, F. A. (2013). The efficacy of licorice gargle for attenuating postoperative sore throat. Am J Res Commun, 1(11), 379-94.
•   Paltura, C., & Yüceant, G. A. (2018). Kisa süreli endotrakeal entübasyonun ses kalitesi ve araligina etkisi. Çagdas Tip Dergisi, 8(1), 26-28.
•   Zaman, F., & Karahan, E. (2020). The Effect of Cold Vapor Treated to Thyroidectomy Patients During Early Postoperative Period. Eastern Journal of Medicine, 25(1), 118-125.