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IRCT20120922010900N6 IRCT 2024-04-29 Kerman University of Medical Sciences Applying an ice pack to the trachea before extubation The effect of applying an ice pack to the trachea before extubation on post-extubation complications in ICU patients: A randomized controlled trial 2024-02-20 anticipated 106 Complete https://irct.ir/trial/74758 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the patients, the block randomization method with 4, 6, and 8 block sizes (with SPSS software) will be used to assign people to two groups. will be. In this method, each person is assigned a unique code and it will help the blinding process. They will be placed in one of the intervention (53 patients) and control (53 patients) groups, Blinding description: The study was blinded for the outcome assessors and the investigator, but not for the patient caregivers who were aware of the group assignments. N/A Intubated patient in the intensive care unit. Intervention 1: Intervention Group: In addition to common treatments, which include the use of a T-tube, Continuous Positive Airway Pressure (CPAP), Synchronized Intermittent Mandatory Ventilation (SIMV), and pressure support methods, a cold compress is applied using ice in a bag placed over the skin of the neck area. This extends from the distal mandible to the sternal notch for a duration of 2 hours by a trained nurse, 2 hours prior to the extubation of the tracheal tube for patient. Intervention 2: Control Group: The standard treatments prior to the separation of the patient from the tracheal tube, depending on the clinical conditions of the patients, may involve one or more methods. These include the use of a T-tube, Continuous Positive Airway Pressure (CPAP), Synchronized Intermittent Mandatory Ventilation (SIMV), and pressure support methods. Yes - There is a plan to make this available What will be shared: Primary outcome information will be shared after de-identification. When: The access period starts 6 months after the results are published To whom: Employees in public and private scientific institutions Conditions: Analysis on the data is not allowed Where to obtain: Hossein Sattari by email Sattari@kmu.ac.ir How to obtain: Immediately after the request Comments:
public Hosien Sattari
Afzalipoor Hospital
Kerman Iran (Islamic Republic of) 7613747181 +98 34 1322 2250 hosattatri@gmail.com Kerman University of Medical Sciences scientific Hoseyn Sattari
Afzalipoor Hospital
Kerman Iran (Islamic Republic of) 7613747181 +98 34 1322 2250 hosattatri@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Intubated people hospitalized in the intensive care unit no limit no limit Both Coughing or harshness of voice before surgery Airway anomaly Previous tracheal surgery history Trauma or neck surgery Previous tracheostomy History of asthma and COPD and respiratory diseases Treatment - Other N/A Intervention Group: In addition to common treatments, which include the use of a T-tube, Continuous Positive Airway Pressure (CPAP), Synchronized Intermittent Mandatory Ventilation (SIMV), and pressure support methods, a cold compress is applied using ice in a bag placed over the skin of the neck area. This extends from the distal mandible to the sternal notch for a duration of 2 hours by a trained nurse, 2 hours prior to the extubation of the tracheal tube for patient Control Group: The standard treatments prior to the separation of the patient from the tracheal tube, depending on the clinical conditions of the patients, may involve one or more methods. These include the use of a T-tube, Continuous Positive Airway Pressure (CPAP), Synchronized Intermittent Mandatory Ventilation (SIMV), and pressure support methods. Need or lack of non-invasive ventilation. Timepoint: At 2, 6, and 24 hours post-extubation. Method of measurement: observation. Hoarseness. Timepoint: At 2, 6, and 24 hours post-extubation. Method of measurement: Based on the criterion of voice violence questionnaire. Cough. Timepoint: At 2, 6, and 24 hours post-extubation. Method of measurement: Based on the criteria of the cough questionnaire. Kerman University of Medical Sciences Approved 2023-10-09 Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences Afzalipour Hospital Kerman Kerman Iran (Islamic Republic of)