The Effect of Cold Vapor on Sore Throat and Dysphagia in the Early Postoperative Period After Suspension Laryngoscopy

March 10, 2022 updated by: Dr. Özlem İbrahimoğlu, Istanbul Medeniyet University
Suspension laryngoscopy (SL) is a surgical procedure that is widely applied in the diagnosis and treatment of many benign or malignant diseases of the vocal cords and allows bimanual surgery of the endolarynx (Larner et al., 2019). In suspension laryngoscopy, a significant force is exerted on the tongue and neck tissues due to the abutment mechanism used to visualize the larynx and pharynx, which are located deeper than the oral cavity. This force causes symptoms such as sore throat, dysphagia, paresis, cough, taste disorder, oral injury, and hoarseness in the postoperative period (Larner et al., 2019; Tsang et al., 2020; Taliercio et al., 2017).In the literature, it has been reported that patients experience sore throat, cough, dysphagia, and hoarseness symptoms after suspension laryngoscopy (Larner et al., 2019; Taliercio et al., 2017; Okui et al., 2020). Pharmacological and non-pharmacological methods can be applied to prevent sore throat and dysphagia after suspension laryngoscopy. The interventions that start while the patient is still in the recovery room to prevent postoperative sore throat and swallowing difficulties are the responsibility of the recovery unit nurses. Being aware of the problems such as sore throat and swallowing difficulties experienced by patients after suspension laryngoscopy, effective nursing practices should be developed to prevent these problems and their possible consequences. Therefore, the aim of this study is to examine the effect of cold vapor on sore throat and dysphagia in the early postoperative period after suspension laryngoscopy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Suspension laryngoscopy (SL) is a surgical procedure that is widely applied in the diagnosis and treatment of many benign or malignant diseases of the vocal cords and allows bimanual surgery of the endolarynx (Larner et al., 2019).In order to prevent any pain and gag reflex, the patients are placed in the supine position, neck hyperextension and head supported position on the operating table for the intervention performed under general anesthesia. With this position, it is aimed to place the microlaryngoscope and to ensure the patient's throat opening (Tsang et al., 2020; Taliercio et al., 2017).

In suspension laryngoscopy, a significant force is exerted on the tongue and neck tissues due to the abutment mechanism used to visualize the larynx and pharynx, which are located deeper than the oral cavity. This force causes symptoms such as sore throat, dysphagia, paresis, cough, taste disorder, oral injury, and hoarseness in the postoperative period (Larner et al., 2019; Tsang et al., 2020; Taliercio et al., 2017).In a study examining the complications experienced by patients after suspension laryngoscopy in the literature, Okui et al. reported that 66% of the patients experienced at least one complication, the most common complication was sore throat with 40%, and tongue numbness with 13.8%, cough with 13.4%, oral injuries with 11.5%, and taste disorders with 11.5% (Okui et al., 2020). In another study, it was reported that the most common postoperative complaints after suspension laryngoscopy were sore throat in 29% and hoarseness in 23% of the patients, while other less common symptoms were cough, frequent throat clearing, intermittent ear pain, and globus sensation (Larner et al., 2019). In another study, it was reported that 76% of the patients described a sore throat that continued for 3 days after the surgery, and that 36% of them continued after the 3rd day after the surgery (Taliercio et al., 2017).

Pharmacological analgesic agents are frequently used to relieve symptoms of sore throat and dysphagia that occur in patients after suspension laryngoscopy (Jung and Kimm, 2013; Paltura et al., 2020). In the literature, there are many studies on the successful application of non-pharmacological agents in the treatment of pain (Bulut et al., 2016; Şahbaz and Khorshid, 2020; Zaman and Karahan, 2020; Guidelenes on the Management of Postoperative Pain, Management of Postoperative Pain, 2016). Patients with post-operative throat complaints are recommended practices that reduce complaints such as taking warm liquids, not taking solid food, sucking ice chips, using lozenges, and applying 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 inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it decreases skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially useful in post-traumatic pain, swelling, and muscle spasm. Although it is seen that pharmacological, non-pharmacological, and herbal methods are applied to reduce postoperative sore throat and dysphagia in the literature, no study has been found examining the effect of cold vapor on sore throat and dysphagia. Therefore, the aim of this study is to examine the effect of cold vapor on sore throat and dysphagia in the early postoperative period after suspension laryngoscopy.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being 18 years or older
  • To undergo suspension laryngoscopy
  • Having an ASA score of 1-2 points
  • 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
  • Having a Modified Mallampati score of 1-2 points
  • Getting 2 points from the Ramsay Sedation scale in the postoperative recovery room
  • Having a Modified Aldrete score of at least 9 points in the postoperative recovery room
  • The duration of the operation is at least 30 minutes
  • 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 a Modified Mallampati score of 3 or higher
  • The duration of the operation is less than 30 minutes
  • Not agreeing to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cold vapor group
Cold vapor will be applied to the 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/nebtime-un600a-ultrasonik-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 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.
Other: Cold vapor
Before surgery, socio-demographic data of the patients, ASA and Mallampati scores, sore throat level, and dysphagia level 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 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.
NO_INTERVENTION: Control group
Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital. Nursing care, which is routinely applied to patients in the postoperative period, both in the recovery room and in the service, will be continued within the standard care. The patients will be evaluated by the researchers in terms of sore throat and dysphagia when they come to the recovery room and at the 6th,12th, and 24th hours after the surgery in the postoperative service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cold vapor
Time Frame: First 24 hours after surgery
The Visual Analogue Scale (VAS) of the patients for sore throat who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the VAS. It is good that the score from the VAS has decreased.
First 24 hours after surgery
Cold vapor
Time Frame: First 24 hours after surgery
The Numeric Rating Scale (RTS) of the patients for dysphagia who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the RTS. It is good that the score from the RTS has decreased.
First 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Collaborators

Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 21, 2022

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (ACTUAL)

March 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulMU11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision will be made after consultation with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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