An interventional study of Catheter Tiemann and Suction catheter in Muscle Weakness, sponsored by Grigoriadis Konstantinos. Completed. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Grigoriadis Konstantinos · Not applicable, Interventional, and Supportive care
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.
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:
In addition to the above, all the parameters needed for calculating the Sequential Organ Failure Assessment score (SOFA) were tabulated, such as:
Finally, it was recorded for each patient before and after the two catheterizations as indicators of disturbance and physiological burden attached to the intervention:
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
To achieve the entrance into the nasopharynx:
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).
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.
605 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 447 interventional studies indexed under Muscle Weakness.
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Exclusion Criteria:
We tested the ability of Tiemman catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention
Device: Catheter Tiemann
We tested the ability of suction catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention
Device: Suction catheter
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
Number of Attempts Before Entering Trachea
We count the required attempts to insert catheter into trachea (number of attempts)
Time frame: An average of 15 seconds
Time to Entering Trachea
We count the required time needed to insert catheter into trachea (seconds).
Time frame: An average of 15 seconds
Respiratory Rate Immediately After Intervention
Recorded the respiratory rate (breaths per minute), immediately after intervention
Time frame: Within 2 seconds after catheter withdrawal.
Heart Rate Immediately After Intervention
Immediately after each intervention recorded the heart rate (beats per minute).
Time frame: Within 2 seconds after catheter withdrawal.
Systolic Blood Pressure Immediately After Each Intervention
Immediately after each intervention recorded the systolic blood pressure (mmHg).
Time frame: Within 2 seconds after catheter withdrawal.
Diastolic Blood Pressure Immediately After Each Intervention
Immediately after each intervention recorded the diastolic blood pressure (mmHg).
Time frame: Within 2 seconds after catheter withdrawal.
Presence of Blood on Catheter Immediately After Each Intervention
Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).
Time frame: Within 2 seconds after catheter withdrawal.
All ICU patients were breathing spontaneously, had respiratory failure of various pathophysiological mechanisms, with impaired cough reflex
| Milestone | Catheter Tiemann First, Then Suction Catheter | Suction Catheter First, Then Catheter Tiemann |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
We count the required attempts to insert catheter into trachea (number of attempts)
| Attempts | Catheter Tiemann | Suction Catheter |
|---|---|---|
| Number of Attempts Before Entering Trachea | 2.63 ± 2.24 | 6.79 ± 3.75 |
We count the required time needed to insert catheter into trachea (seconds).
| Sec | Catheter Tiemann | Suction Catheter |
|---|---|---|
| Time to Entering Trachea | 10.05 ± 10.074 | 20.06 ± 12.694 |
Recorded the respiratory rate (breaths per minute), immediately after intervention
| Βreaths per minute | Catheter Tiemann | Suction Catheter |
|---|---|---|
| Respiratory Rate Immediately After Intervention | 26.37 ± 7.544 | 25.79 ± 7.941 |
Immediately after each intervention recorded the heart rate (beats per minute).
| Βeats per minute | Catheter Tiemann | Suction Catheter |
|---|---|---|
| Heart Rate Immediately After Intervention | 87.21 ± 15.623 | 86.53 ± 14.013 |
Immediately after each intervention recorded the systolic blood pressure (mmHg).
| mmHg | Catheter Tiemann | Suction Catheter |
|---|---|---|
| Systolic Blood Pressure Immediately After Each Intervention | 143.37 ± 24.703 | 141.32 ± 19.136 |
Immediately after each intervention recorded the diastolic blood pressure (mmHg).
| mmHg | Catheter Tiemann | Suction Catheter |
|---|---|---|
| Diastolic Blood Pressure Immediately After Each Intervention | 62.74 ± 13.482 | 60.32 ± 11.856 |
Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).
| Catheters with presence of blood | Catheter Tiemann | Suction Catheter |
|---|---|---|
| Presence of Blood on Catheter Immediately After Each Intervention | 6 | 6 |
Collected over 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Catheter Tiemann | — | 0/20 (0%) | 6/20 (30%) |
| Suction Catheter | — | 0/20 (0%) | 6/20 (30%) |
| Event | Catheter Tiemann | Suction Catheter |
|---|---|---|
| Presence of Blood on CatheterInjury, poisoning and procedural complications | 6/20 | 6/20 |
The participants were non intubated ICU patients who had inadequate cough leading to the inability to mobilize their secretions. The inadequate cough is result of neuromuscular disorders, ICU neuromyopathy, abdominal pain due to surgery and low consiousness due to head injuries.
| Age, Customized(participants) | Catheter Tiemann First, Then Suction Catheter | Suction Catheter First, Then Catheter Tiemann | Total |
|---|---|---|---|
| <60 years | 1 | 0 | 1 |
| 60-69 years | 2 | 2 | 4 |
| 70-79 years | 3 | 3 | 6 |
| >80 years | 4 | 5 | 9 |
| Sex: Female, Male(Participants) | Catheter Tiemann First, Then Suction Catheter | Suction Catheter First, Then Catheter Tiemann | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 5 | 5 | 10 |
| SOFA(participants) | Catheter Tiemann First, Then Suction Catheter | Suction Catheter First, Then Catheter Tiemann | Total |
|---|---|---|---|
| <4 | 7 | 7 | 14 |
| 6 | 2 | 2 | 4 |
| 9 | 1 | 1 | 2 |
| Hospitalisation day(participants) | Catheter Tiemann First, Then Suction Catheter | Suction Catheter First, Then Catheter Tiemann | Total |
|---|---|---|---|
| < 5 days | 2 | 2 | 4 |
| ≥ 5 days, < 10 days | 3 | 3 | 6 |
| ≥ 10 days | 5 | 5 | 10 |
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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