Effectiveness of premeasured minimally invasive endotracheal suction on physiological parameters in mechanically ventilated infants: a clinical trial study

Determining the effectiveness of pre-measured tracheal suction on physiological indicators in infants

This clinical trial study with control group, one-sided blind, randomized, phase 3 will be conducted on 30 infants. Based on the random allocation method, with the block method in blocks of six (produced by Random Allocation Software) to one of two groups A (pre-measured suction, routine suction) and group B (routine suction, pre-suction) measured), will be allocated 1:1.

In this study, the effect of two suction methods on the physiological indicators of infants hospitalized in the NICU department of Amirkola Children's Hospital is compared. Infants and nurses cannot be blinded, blinding will only be done for the data analyst.

Inclusion criteria include: 1- Term infants who are connected to a ventilator 2- stable physiological and clinical conditions of the infant 3- have not received surfactant in the last six hours Exclusion criteria include: 1- Infants who experience a severe drop in blood oxygen saturation during tracheal tube suction. 2- Before completing the study data, the infant should be sent to another medical center for further treatment. 3- Changing the type of intra tracheal suction for any reason during the entire hospitalization period.

In group A, if the infants need suction, they will first receive tracheal tube suction in a pre-measured method for 12 hours, and in the next 12 hours, they will be subjected to suction in a routine method. In group B, infants first receive tracheal tube suction by routine method for 12 hours, and then during the next 12 hours, they will be subjected to pre-measured suction.

Changes in the physiological indicators of infants during and after suctioning

Considering that the infants under study are not included in the study at the same time and the researchers cannot predict in advance which group each baby who enters the study will belong to, in order to assign the infants to one of the two study groups, using the method Block Randomization with blocks of 6 will be used. In this way, according to the block random division protocol (produced by Random Allocation Software) into one of two groups A (pre-measured suction, routine suction) and B (routine suction, pre-measured suction), 1:1 will be allocated, so that the researcher cannot predict which group of intervention and control the method of suctioning in each baby will be. In order to hide the random assignment of the codes generated by the software, they will be placed in sealed opaque envelopes so that the next person who will be assigned to which group will not be known. Based on the sample size, a number of opaque mail envelopes, preparation and each of the randomly created sequences are recorded on a card and the cards are placed inside the mail envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration, based on the order of entry of qualified infants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.

In this study, due to the fact that after randomization, both the infants and the nurses cannot be blinded (because the type of intervention is known), therefore blinding cannot be done in the first stage. On the other hand, the measurement of all outcomes in this study is objective. Blinding will be done only for the evaluator and data analyst.

Data on primary and secondary outcomes

6 months after the publication of the results

All interested people

The use of the results of this study is allowed in compliance with ethical principles.

via the corresponding author's email (Ali Zabihi) zabihi_alii@yahoo.com

Applicants will receive the results via email after one week.