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Nasotracheal Suction With Tiemann Catheter Compared to the Classic Technique With the Suction Catheter

Randomized Controlled Study of Nasotracheal Suction With Tiemann Catheter Compared to the Classic Technique With the Standard One.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02261428
Enrollment
20
Registered
2014-10-10
Start date
2014-05-31
Completion date
2014-09-30
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Weakness

Keywords

Nasotracheal suction, tracheal access

Brief 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 fingertipwas 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.

Interventions

DEVICECatheter Tiemann

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

Sponsors

Grigoriadis Konstantinos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* ICU patients with nasogastric tube and spontaneous breathing without artificial airway * Inability to mobilize and handle secretions * Glasgow Coma Scale (GCS) \>12/15 * PaO2/FiO2 ratio \>100

Exclusion criteria

* Active nasal bleeding * international normalized ratio (INR)\>3 * Glasgow Coma Scale (GCS) \<11/15 * Facial or basal cranial fractures * Tumor in trachea * Pregnancy * ICU patients with endotracheal tube or tracheostomy tube

Design outcomes

Primary

MeasureTime frameDescription
Number of Attempts Before Entering TracheaAn average of 15 secondsWe count the required attempts to insert catheter into trachea (number of attempts)

Secondary

MeasureTime frameDescription
Respiratory Rate Immediately After InterventionWithin 2 seconds after catheter withdrawal.Recorded the respiratory rate (breaths per minute), immediately after intervention
Heart Rate Immediately After InterventionWithin 2 seconds after catheter withdrawal.Immediately after each intervention recorded the heart rate (beats per minute).
Time to Entering TracheaAn average of 15 secondsWe count the required time needed to insert catheter into trachea (seconds).
Diastolic Blood Pressure Immediately After Each InterventionWithin 2 seconds after catheter withdrawal.Immediately after each intervention recorded the diastolic blood pressure (mmHg).
Presence of Blood on Catheter Immediately After Each InterventionWithin 2 seconds after catheter withdrawal.Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).
Systolic Blood Pressure Immediately After Each InterventionWithin 2 seconds after catheter withdrawal.Immediately after each intervention recorded the systolic blood pressure (mmHg).

Participant flow

Recruitment details

All ICU patients were breathing spontaneously, had respiratory failure of various pathophysiological mechanisms, with impaired cough reflex

Pre-assignment details

Of the 30 patients screened during the run-in period between May 2014 and September 2014 they received nasotracheal suction all. 10 of them required for pilot study and 20 for the main study. The pilot study was designated as a separate study and the participants was not included in this record.

Participants by arm

ArmCount
Catheter Tiemann First, Then Suction Catheter
Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
10
Suction Catheter First, Then Catheter Tiemann
Participants first received nasotracheal suction with Suction catheter . After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
10
Total20

Baseline characteristics

CharacteristicCatheter Tiemann First, Then Suction CatheterSuction Catheter First, Then Catheter TiemannTotal
Age, Customized
60-69 years
2 participants2 participants4 participants
Age, Customized
<60 years
1 participants0 participants1 participants
Age, Customized
70-79 years
3 participants3 participants6 participants
Age, Customized
>80 years
4 participants5 participants9 participants
Hospitalisation day
≥ 10 days
5 participants5 participants10 participants
Hospitalisation day
< 5 days
2 participants2 participants4 participants
Hospitalisation day
≥ 5 days, < 10 days
3 participants3 participants6 participants
Sex: Female, Male
Female
5 Participants5 Participants10 Participants
Sex: Female, Male
Male
5 Participants5 Participants10 Participants
SOFA
<4
7 participants7 participants14 participants
SOFA
6
2 participants2 participants4 participants
SOFA
9
1 participants1 participants2 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
6 / 206 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Catheter TiemannNumber of Attempts Before Entering Trachea2.63 AttemptsStandard Deviation 2.24
Suction CatheterNumber of Attempts Before Entering Trachea6.79 AttemptsStandard Deviation 3.75
p-value: <0.0595% CI: [1.79, 8.73]Wilcoxon (Mann-Whitney)
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Catheter TiemannDiastolic Blood Pressure Immediately After Each Intervention62.74 mmHgStandard Deviation 13.482
Suction CatheterDiastolic Blood Pressure Immediately After Each Intervention60.32 mmHgStandard Deviation 11.856
Secondary

Heart Rate Immediately After Intervention

Immediately after each intervention recorded the heart rate (beats per minute).

Time frame: Within 2 seconds after catheter withdrawal.

ArmMeasureValue (MEAN)Dispersion
Catheter TiemannHeart Rate Immediately After Intervention87.21 Βeats per minuteStandard Deviation 15.623
Suction CatheterHeart Rate Immediately After Intervention86.53 Βeats per minuteStandard Deviation 14.013
Secondary

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.

ArmMeasureValue (NUMBER)
Catheter TiemannPresence of Blood on Catheter Immediately After Each Intervention6 Catheters with presence of blood
Suction CatheterPresence of Blood on Catheter Immediately After Each Intervention6 Catheters with presence of blood
Secondary

Respiratory Rate Immediately After Intervention

Recorded the respiratory rate (breaths per minute), immediately after intervention

Time frame: Within 2 seconds after catheter withdrawal.

ArmMeasureValue (MEAN)Dispersion
Catheter TiemannRespiratory Rate Immediately After Intervention26.37 Βreaths per minuteStandard Deviation 7.544
Suction CatheterRespiratory Rate Immediately After Intervention25.79 Βreaths per minuteStandard Deviation 7.941
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Catheter TiemannSystolic Blood Pressure Immediately After Each Intervention143.37 mmHgStandard Deviation 24.703
Suction CatheterSystolic Blood Pressure Immediately After Each Intervention141.32 mmHgStandard Deviation 19.136
Secondary

Time to Entering Trachea

We count the required time needed to insert catheter into trachea (seconds).

Time frame: An average of 15 seconds

Population: The 19 interventions with each catheter was used randomly

ArmMeasureValue (MEAN)Dispersion
Catheter TiemannTime to Entering Trachea10.05 SecStandard Deviation 10.074
Suction CatheterTime to Entering Trachea20.06 SecStandard Deviation 12.694

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026