Nasotracheal Suction With Tiemann Catheter Compared to the Classic Technique With the Suction Catheter
Condition: Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      The study compares the effectiveness of Tiemann and Suction catheters, with regard to
      attempts to enter the trachea and the time required for the procedure.
    

Detailed description: 
      The population of the study was twenty (20) patients, hospitalized in General and
      Cardiothoracic ICU, mostly with respiratory failure of various etiologies, the majority of
      which has complicated with Unit Myoneuropathy. This state confirmed by medical research
      council (MRC) Sum score which gave a result less than 48/6011 which corresponds to thirteen
      (13) patients in the total population of the study.

      The randomization of the study achieved using the sealed envelopes method and associated with
      the catheter to be first used in the suction9,10 (Tiemann or suction catheter).

      Twenty (20) sealed envelopes were prepared from a team not related to the study. The sealed
      envelopes had an inside paper with the sign "T" for the first ten (10) envelopes and "N" for
      the rest ten (10) of them.

      When a new patient met the criteria for this study, one sealed envelope was randomly selected
      to determine the technique would come first: "T" for Tiemann technique or "N" for Suction
      catheter technique.

      Furthermore the following parameters tabulated for each patient:

        -  Sex

        -  Unit

        -  Cause input

        -  First catheter used

        -  Second catheter used

        -  Hospitalization day

        -  Age

        -  Possible causes weakness

        -  Percentage oxygen mixture fraction of inspired oxygen (FiO2) and

        -  Oxygen partial pressure (PaO2) before any action

      In addition to the above, all the parameters needed for calculating the Sequential Organ
      Failure Assessment score (SOFA) were tabulated, such as:

        -  Bilirubin

        -  The Glasgow Coma Score

        -  Platelets

        -  Mean arterial pressure

        -  Creatinine and urine 24 hours

      Finally, it was recorded for each patient before and after the two catheterizations as
      indicators of disturbance and physiological burden attached to the intervention:

        -  The systolic and diastolic blood pressure

        -  The respiratory rate

        -  The heart rate

        -  The saturation of hemoglobin

        -  The blood gases, which recorded the partial pressure of oxygen (PaO2), carbon dioxide
           carbon dioxide partial pressure (PaCO2), the Ph and bicarbonates (HCO3).

      A first check took place to identify each patient who met the admission criteria for the
      study.

      The procedure required two people skilled in the nasotracheal suction (NTS), the first one to
      perform the NTS and the other one to record the time and the attempts needed, and it was
      beginning by correcting the posture of each patient on the bed, when the Great Trochanter was
      more than 20 centimeters away from the hinge of the bed.

      The pillow beneath the patient's head was removed to have an extended position, the first
      blood gas analysis was done and the parameters mentioned above were recorded in the relevant
      tables.

      To determine the access of the trachea, it was used a stethoscope to hear turbulent flow on
      the anterior surface of the chest.

      The whole procedure comprises two "steps":

      a) Achieving of the entrance into the nasopharynx b) Achieving of the entrance into the
      trachea

        1. To achieve the entrance into the nasopharynx:

             -  It was selected the opposite nostril that Levine was placed.

             -  The insertion of the catheter was always opposite to the medial canthus of the eye.

             -  If it was found resistance and the catheter was not inserted to the nasopharynx, it
                was pulled slightly outwardly and then inwardly.

           Each kind of micromanipulation recorded as attempt. The maximum number of attempts were
           agreed in Protocol Design (beyond which the attempts would stop) was five (5). In fact,
           in no cases was exceeded the limit of five attempts.

           The time recorded corresponds to the time needed for the successful advancement of the
           catheter in the nasopharynx through the nostril (T1).

        2. Achieving of the entrance into the trachea:

      The successful insertion of the catheter into the trachea was confirmed by another member of
      the team using stethoscope and was determined by:

      i. Hearing of turbulent flow when closing the "fingertip" ii. Insertion without resistance
      iii. Tickly cough during the insertion.

      The insertion to trachea was considered to be unsuccessful as the catheter insert into the
      esophagus and thus:

      i. There was no production of turbulent airflow when the hole of "fingertip"was closed ii. It
      was found resistance during the insertion of the catheter iii. There was a grimace of disgust
      on the patient's face. As the insertion was considered to be unsuccessful according to the
      above conditions, catheter was drawn slightly outward (less than one centimeter) and
      redirected to the trachea.

      Each kind of micromanipulation recorded as attempt. The maximum number of attempts were
      agreed in Protocol Design was ten (10). Beyond the above limit the insertion was considered
      to be unsuccessful and repeated after half an hour15 with the other catheter (half an hour is
      the sufficient time for the patient to return to his initial condition).

      The time of the second "step" recorded, corresponds to the time needed for the successful
      promotion of the catheter from the nasopharynx to the trachea (T2).

      Finally it was recorded the time needed for each suction which was tabulated below as (T3).

      The summation of (T1), (T2) and (T3) was reflected the total time needed for the whole
      procedure which was followed by a new blood gas analysis.

      All parameters were recorded by the team involved to the study. The catheters used for this
      study were 14 French dia. of the same industry and from the same material (medical PVC).

      As it was mentioned above, the whole idea based on the J-shape of the Tiemann catheter which
      is useful for the orientation of the catheter during the insertion to the nasopharynx first
      and then into the trachea and placed always downwards.

      The oxygen face mask was maintained during the insertion of the catheter in order to continue
      the patient's oxygenation and avoid hypoxemia. This was achieved by leaving outside the
      oxygen face mask only the opposite nostril of the nasogastric tube.

      No extra oxygen was given to patients before the procedure as pre-oxygenation.

      The size of the sample was calculated based on a pilot study and was determined to twenty
      (20) patients were not included in the main study. Thus ten (10) patients underwent an equal
      number of nasotracheal suctioning with Tiemann catheter and ten (10) with Suction catheter.

      For standard deviation σ1=3.9, and an error α=0,05 and power 80, the sample size must be
      bigger than twelve (12).

      From all the above the investigators summarize that the sample size of twenty (20) patients
      was adequate.

      For the statistical analysis was used the SPSS 20 Inc., Chicago, IL, and for paired values
      the Paired T-Test and Wilcoxon Signed Rank Test.

      For paired nominal parameters was used the McNemar Χ2 test. To determine normal
      distributions, was used the Kolmogorov-Smirnov test. In the majority of cases data are
      presented as Median (Range) in abnormal distributions and Mean (SD) in normal.

      Odds ratio was used to quantify how strongly Tiemann associated with Suction catheter in
      total attempts.

      Significance was taken as P < 0.05. To determine the difference in time needed by using the
      two catheters was used Kaplan-Mayer analysis and long-rank test.
    

Intervention name(s): Catheter Tiemann; Suction catheter
Intervention type(s): Device; Device
Intervention description(s): We tested the ability of Tiemann catheter to access trachea in order to aspirate bronchial secretions in ICU patients; We tested the ability of Suction catheter to access trachea in order to aspirate bronchial secretions in ICU patients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Nasotracheal suction, tracheal access