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IRCT20201109049319N1 IRCT 2020-12-10 Tabriz University of Medical Sciences Pressure-controlled inverse ratio ventilation during laryngeal mask airway anesthesia Effect of Pressure-controlled inverse ratio ventilation during laryngeal mask airway anesthesia on ventilatory parameters 2020-05-21 anticipated 80 Complete https://irct.ir/trial/52407 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be using sealed envelopes, of which 80 envelopes will be selected in total and will be divided into two groups of 40, including groups A and B. Envelopes will be selected by the operating room nurse who is blind to the study groups. Group A will be the usual pressure ventilation group, group B will be the reverse pressure ventilation group, Blinding description: The operating room nurse, who chooses sealed envelopes, will be blinded about patients groups. N/A Pressure-controlled inverse ratio ventilation during laryngeal mask airway anesthesia. Intervention 1: Intervention group: Compression ventilation group with normal ratio ratio of inhalation to exhalation 1 to 2), maximum airway pressure will be adjusted so that the current volume of 6 ml/kg based on the ideal body weight is delivered to the patient's lungs and after starting Respiratory rate with 8 to 10 per minute, then the number of breaths to maintain carbon dioxide at the end of exhalation between 30 to 35 mm Hg will be changed as needed. Intervention 2: Intervention group: Compression ventilation group with inverse ratio (ratio of inhalation to exhalation 1.5 to 1), the maximum airway pressure will be adjusted so that the current volume of 6 ml/kg based on the ideal body weight is delivered to the patient's lungs and then From the beginning of the number of breaths with 8 to 10 per minute, then the number of breaths to maintain carbon dioxide at the end of the exhalation between 30 to 35 mm Hg will be changed as needed. Yes - There is a plan to make this available What will be shared: Study data is categorized and coded with no identifiable individuals. When: Access to study data after publication of the result is available in the journal. To whom: Anyone interested in using the data can access the study data. Conditions: Study data can be used for comparison with other results. Where to obtain: Refer to the study's scientific or public accountability person for data. How to obtain: The request will be sent by email to person responsible for scientific or public inquiries. Comments:
public Mahkam Rezvani
Unit 10, First enterance, Negin 2 apartment, Kouhsar Blvd., Roshdiyeh Town
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3668 6556 mahkam.rezvanii@gmail.com Tabriz University of Medical Sciences scientific Mahkam Rezvani
Unit 10, First enterance, Negin 2 apartment, Kouhsar Blvd., Roshdiyeh Town
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3668 6556 mahkam.rezvanii@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) ASA class one and two Candidate for cataract surgery under general anesthesia using laryngeal mask 20 years 70 years Both Perform surgery under local anesthesia Lung disease BMI > 30 kg/m2 Patients with obstructive sleep apnea Patients with a history of gastroesophageal reflux Reluctance to participate in the study Age under 20 years Age over 70 years People with mental disabilities H25 Age-related cataract N/A N/A Intervention group: Compression ventilation group with normal ratio ratio of inhalation to exhalation 1 to 2), maximum airway pressure will be adjusted so that the current volume of 6 ml/kg based on the ideal body weight is delivered to the patient's lungs and after starting Respiratory rate with 8 to 10 per minute, then the number of breaths to maintain carbon dioxide at the end of exhalation between 30 to 35 mm Hg will be changed as needed. Intervention group: Compression ventilation group with inverse ratio (ratio of inhalation to exhalation 1.5 to 1), the maximum airway pressure will be adjusted so that the current volume of 6 ml/kg based on the ideal body weight is delivered to the patient's lungs and then From the beginning of the number of breaths with 8 to 10 per minute, then the number of breaths to maintain carbon dioxide at the end of the exhalation between 30 to 35 mm Hg will be changed as needed. Maximum airway pressure. Timepoint: 1, 5, 10 and 20 minutes after the start of anesthesia. Method of measurement: Ventilator device monitor. Airway dynamic compliance. Timepoint: 1, 5, 10 and 20 minutes after the start of anesthesia. Method of measurement: Ventilator device monitor. Expiratory volume of exhalation. Timepoint: 1, 5, 10 and 20 minutes after the start of anesthesia. Method of measurement: Ventilator device monitor. Arterial blood oxygen saturation. Timepoint: 1, 5, 10 and 20 minutes after the start of anesthesia. Method of measurement: Ventilator device monitor. Tabriz University of Medical Sciences Approved 2019-10-14 Ethics committee of Tabriz University of Medical Sciences Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah Square Tabriz East Azarbaijan Iran (Islamic Republic of)