Comparing two levels of closed system suction pressure in ICU patients: Evaluating the relative safety of higher values of suction pressure

This study was designed to evaluate the effects on gas exchange and suctioning volume of tow levels of suctioning pressure in close suctioning system.

Clinical trial, tow Intervention groups with cross over design, double blinded, randomized with computer base minimization software

50 adult ICU patients are studied. The study involve consecutive application of two different suction pressures of 100 and 200 mmHg to each patient. To make the carry over effect as low as possible, the order of applying suction pressure are randomly chosen for each subject. Assignment of subjects to each group and setting the suction pressure for each round of suctioning are carried out by the second researcher in position, who is not participated in the act of suctioning and data measurements. Chief researcher, who performe the suctioning procedure, is blinded regarding the level of suction pressure and patient’s assigned group.

ICU patients, older than 18 years, undergoing mechanical ventilation, using volume modes, 24 hour after intubation time, with orotracheal intubation and no sever hypoxemia (SpO2 < 85%, PaO2 < 50 mmHg),and stable hemodynamic condition (MAP > 70 mmHg,HR < 130/min) will enter to this study. Patients with hemodynamic instability (DBP > 100 mmHg, ↑ or ↓ 20 mmHg in SBP, SpO 2 < 85% and ↑ 20 b/min in HR) and those requiring suctioning in wash out period, and when the patient’s family are unwilling to enter and continue the research do not enter to the study.

Intervention groups are divided into two groups, first AB and BA second group. Patients in AB group receive 100 mmHg suction pressures first, and then 200 mmHg after tow hour of washout period. BA group receive reverse order.

SpO2, heart rate and suctioning volume are recorded before, 1,3 and 20 minutes after suctioning.

isfahan university of medical science

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.

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.

Part of the data on patients' information and their outcomes can be shared.

Access start has no limits.

Academic and scientific researchers

Possibility and determination of access to data and analyzes is allowed after obtaining permission from the university's research and technology vice president.

Research department, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran, Tell 00983137927533

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