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IRCT20110912007529N18 IRCT 2018-10-19 Shahed University The effect of humidifier therapy on postextubation complications in older people The effect of humidifier therapy on postextubation complications in older people after coronary artery bypass surgery 2018-09-23 anticipated 80 Complete https://irct.ir/trial/33835 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Eligible patients will be selected through convenience sampling and will be randomly assigned into 2 groups using permuted block randomization with allocation ratio of 1:1. Random allocation sequence will be determined using a computerized program. Opaque sealed sequentially numbered envelopes from number 1 to 80 will be used for allocation concealment, Randomization description: Eligible patients will be randomly assigned into two groups using permuted block randomization , Random numbers table will be used, Random allocation sequence will be determined using a computerized program.Opaque sealed sequentially numbered envelopes from number 1 to 80 will be used for allocation concealment, Blinding description: Outcome assessor, staff nurses in the ICU and the statistical analyzer will be blind to patients’allocation of the groups. N/A Condition 1: Nausea. Condition 2: Hoarseness. Condition 3: Cough. Condition 4: Sore Throat. Intervention 1: Intervention group: The 45 elderly patients receive ward routine care and also cool mist using nebulizer. The intervention group receive cool mist for 45 minutes before extubation and 45 minutes after extubation (90 min. overall). Intervention 2: Control group: The 45 elderly patients in control group receive only ward routine care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is If the university agrees, it will be done
public Nahid Rejeh
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 3071 nrejeh@yahoo.com Shahed University scientific Nahid Rejeh
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 3071 nrejeh@yahoo.com Shahed University Iran (Islamic Republic of) age above of 60 years، the absence of any cognitive impairment، patients with first undergoing surgery coronary artery bypass، history of having respiratory disease or sore throat during the preceding week، lack of drug addiction، conscious patients، Anesthesia duration between 4 to 6 hours، four to five hours operation time، having endotracheal tube between 6 to 8 hours after the end surgery، 60 years no limit Both Patient with no cooperation to end of study، physician disagreement، Re-intubation tracheal tube after extubation for any reason، intubation more than 30 seconds، attempt for intubation more than once، traumatizing trachea (during intubation)، report of difficult intubation (mallampati intubation score of higher than class ii )، Death of patient during the study، Daley of extubation process R11.0 R49.0 R05 J02 Nausea Dysphonia psychogenic cough acute sore throat Prevention Prevention Intervention group: The 45 elderly patients receive ward routine care and also cool mist using nebulizer. The intervention group receive cool mist for 45 minutes before extubation and 45 minutes after extubation (90 min. overall). Control group: The 45 elderly patients in control group receive only ward routine care. Hoarseness. Timepoint: immediately after , 6,12,18, and 24 hrs. after extubation. Method of measurement: four-point scale. Nausea. Timepoint: immediately after , 6,12,18, and 24 hrs. after extubation. Method of measurement: four-point scale. Cough. Timepoint: immediately after , 6,12,18, and 24 hrs. after extubation. Method of measurement: four-point scale. Sore throat. Timepoint: immediately after , 6,12,18, and 24 hrs. after extubation. Method of measurement: four-point scale. Shahed University Approved 2018-09-03 Ethics committee of Shad University Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)