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IRCT20160924029930N2 IRCT 2018-07-20 Esfahan University of Medical Sciences Comparing two levels of closed system suction pressure in ICU patients: Evaluating the relative safety of higher values of suction pressure suction pressure . closed suctioning system Comparing two levels of closed system suction pressure in ICU patients: Evaluating the relative safety of higher values of suction pressure 2010-05-22 anticipated 50 Complete https://irct.ir/trial/23933 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: We use a minimization model. we can minimize the differences between two groups (AB, BA) and at the same time to enroll subjects randomly into groups, hence eliminating selection bias and the predictability of subject assignment. To further decrease the carry over effect, we incorporate a wash‑out period of two hours between two episodes of suctioning. Minimization factors included age, gender, base SpO2, admission diagnosis, ventilator mode, and length of ICU stay, Blinding description: Chief researcher, who performed the suctioning procedure, was blinded regarding the level of suction pressure and patient’s assigned group. Assignment of subjects to each group and setting the suction pressure for each round of suctioning were carried out by the second researcher in position, who was not participated in the act of suctioning and data measurements. Patients were also blinded regarding the level of suction pressure. N/A Oxygenation of patient under endotracheal suctioning with closed suctioning system. Intervention 1: Intervention group 1: Two consecutive ten seconds closed suctioning system using suction pressures of 100 at first and then 200 mmHg will do with 2 hour washout period between each suctioning. Intervention 2: Intervention group 2: Two consecutive ten seconds closed suctioning system using suction pressures of 200 at first and then 100 mmHg will do with 2 hour washout period between each suctioning. Yes - There is a plan to make this available What will be shared: Part of the data on patients' information and their outcomes can be shared. When: Access start has no limits. To whom: Academic and scientific researchers Conditions: Possibility and determination of access to data and analyzes is allowed after obtaining permission from the university's research and technology vice president. Where to obtain: Research department, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran, Tell 00983137927533 How to obtain: Submitting a written request regarding the cause of the need for access to the documentation of the research and the introduction of the applicant to the Vice-Chancellor of Research of the Faculty of Nursing and Midwifery of Isfahan Comments:
public Somayeh Haghighat Borujeni
Hezar Jarib Ave, Isfahan University of Medical Science, Faculty of Nursing and Midwify, Critical Care Nursing Department
Isfahan Iran (Islamic Republic of) 8174673465 +98 31 3792 7576 s_haghighat@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Somayeh Haghighat Borujeni
Hezar jarib Ave, Isfahan University of Medical Science. Faculty of Nursing and Midwifery, Critical Care Nursing Department
Isfahan Iran (Islamic Republic of) 8174673465 +98 31 3792 7576 s_haghighat@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) patients older than 18 years hospitalized in ICU undergoing mechanical ventilation using volume modes 24 hour after intubation time with orotracheal intubation with no sever hypoxemia (SpO2 < 85%, PaO2 < 50 mmHg) stable hemodynamic condition (MAP > 70 mmHg,HR < 130/min) 18 years no limit Both Patients wit hemodynamic instability (DBP > 100 mmHg, ↑ or ↓ 20 mmHg in SBP, SpO 2 < 85% and ↑ 20 b/min in HR) those requiring suctioning in wash out period when the patient or patient’s family was unwilling to participate and continue the research Treatment - Other Treatment - Other Intervention group 1: Two consecutive ten seconds closed suctioning system using suction pressures of 100 at first and then 200 mmHg will do with 2 hour washout period between each suctioning. Intervention group 2: Two consecutive ten seconds closed suctioning system using suction pressures of 200 at first and then 100 mmHg will do with 2 hour washout period between each suctioning. SPO2. Timepoint: before. 1,3 and 20 min after suctioning. Method of measurement: measures from pulseoximetery. Heart rate and hemodynamic instability. Timepoint: befor, during and 20 min after suctioning. Method of measurement: measures from heart monitoring. Secretion volume in endotracheal suctioning. Timepoint: after each suctioning. Method of measurement: graded container attached to bottle of suction device. Esfahan University of Medical Sciences Approved 2011-07-18 Ethical Committee of Isfahan University of Medical Science Isfahan. Hezar Jarib Avn. Isfahan University of Medical Science, Faculty of Nursing and Midwifery Isfahan Isfehan Iran (Islamic Republic of)