Comparison of different levels of positive end-expiratory pressure on the respiratory function in laparoscopic cholecystectomy candidates

Comparison of 0, 5 and 7 cm H2O positive end-respiratory pressure on the respiratory function of laparoscopic cholecystectomy candidates

Phase III single-blind (assessor-blind) randomized controlled trial with parallel groups on 75 patients, randomization will be performed using a randomization table generated by the Random Allocation software.

This study will be performed on 75 laparoscopic cholecystectomy candidates in Shahid Mohammadi Hospital, Bandar Abbas. Patients will be randomized into three groups based on a randomization table. Patients in intervention groups 1 and 2 and the control group will receive positive end-expiratory pressure of 5, 7, and 0 cm H2O, respectively. The respiratory and cardiac parameters will be assessed by an individual blinded to patient grouping (assessor-blind).

Inclusion criteria: age 18-70 years, ASA class I and II Exclusion criteria: hemodynamic instability, severe heart failure, renal failure, respiratory failure, pulmonary embolism, air embolism during the operation, complications of laparoscopy leading to laparotomy, history of chronic respiratory diseases, asthma, and chronic obstructive pulmonary disease

Intervention group 1: positive end-expiratory volume (PEEP) of 5 cm H2O Intervention group 2: PEEP of 7 cm H2O Control group: PEEP of 0 cm H2O

Partial pressure of oxygen in arterial blood (PaO2)

Patients will be randomized into two groups using simple randomization with individuals as the unit of randomization and a randomization table produced by the Random Allocation software. An individual uninvolved in the study will write A or B or C on a card and put it in an opaque envelope. Then the associated number in the randomization table will be written on the back of the envelope. One envelope will be allocated to each patient in order of entrance to the study. Allocation concealment will be done using opaque envelopes.

The individual responsible for the assessment of hemodynamic and respiratory parameters will be unaware of patient grouping, while given the nature of the intervention and that there is no placebo, the patient and those related to the patient will not be blinded. Therefore, the study will be single-blind with blinding the assessor.

There is no further information.