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

Not Applicable

• Conditions: Cough; Sore Throat; Hoarseness; Intubation Complication; Cold; Dysphagia
• Interventions: Other: Cold vapor

• Registration Number: NCT05317156
• Lead Sponsor: Istanbul Medeniyet University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-08
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-04
• Last Update Submitted: 2022-04-04
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07
• Study Start: 2022-04-18
• Primary Completion: 2022-10-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prone position-Cold vapor group	Cold vapor	Cold vapor will be applied to the prone position experimental group patients for 15 minutes in the recovery room. For the study, Nebtime UN600A Ultrasonic Nebulizer Device will be used to apply cold steam to the patients which used in the hospital and calibrated (https://elmaslarmedikal.com.tr/urunler/nebtimeun600aultrasonik-nebulizator/). 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 (1-10), air blowing intensity 5 (1-10), 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.
Supine position-Cold vapor group	Cold vapor	Cold vapor will be applied to the supine position experimental group patients for 15 minutes in the recovery room. For the study, Nebtime UN600A Ultrasonic Nebulizer Device will be used to apply cold steam to the patients which used in the hospital and calibrated (https://elmaslarmedikal.com.tr/urunler/nebtimeun600aultrasonik-nebulizator/). 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 (1-10), air blowing intensity 5 (1-10), 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.

Primary Outcome Measures

Name	Time	Method
Cold vapor	24th hour after surgery	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.