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CompletedNCT02261428Updated Mar 17, 2015Results posted

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
45 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Muscle Weakness

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Keywords

  • Nasotracheal suction, tracheal access
03

In context

Muscle Weakness

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.

Browse Muscle Weakness studies →

Lead sponsor

This is the only study on the registry with Grigoriadis Konstantinos as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Catheter Tiemann

    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

  • Active comparator
    Suction catheter

    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

Interventions

  • DeviceCatheter Tiemann

    We tested the ability of Tiemann catheter to access trachea in order to aspirate bronchial secretions in ICU patients

  • DeviceSuction catheter

    We tested the ability of Suction catheter to access trachea in order to aspirate bronchial secretions in ICU patients

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to Entering Trachea

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

    Time frame: An average of 15 seconds

  2. Respiratory Rate Immediately After Intervention

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

    Time frame: Within 2 seconds after catheter withdrawal.

  3. Heart Rate Immediately After Intervention

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

    Time frame: Within 2 seconds after catheter withdrawal.

  4. 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.

  5. 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.

  6. 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.

07

Results

Posted Mar 17, 2015

Participant flow

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

Participant flow — Overall Study
MilestoneCatheter Tiemann First, Then Suction CatheterSuction Catheter First, Then Catheter Tiemann
Started1010
Completed1010
Not completed00

Outcome measures

PrimaryNumber 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
Reported as:
Mean · Attempts
Number of Attempts Before Entering Trachea
AttemptsCatheter TiemannSuction Catheter
Number of Attempts Before Entering Trachea2.63 ± 2.246.79 ± 3.75
Statistical analysis
  • Catheter Tiemann vs Suction Catheter · Wilcoxon (Mann-Whitney) · p = <0.05 · Odds ratio (or): 3.95 · 95% CI 1.79 to 8.73
SecondaryTime to Entering Trachea

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

Time frame:
An average of 15 seconds
Reported as:
Mean · Sec
Time to Entering Trachea
SecCatheter TiemannSuction Catheter
Time to Entering Trachea10.05 ± 10.07420.06 ± 12.694
SecondaryRespiratory Rate Immediately After Intervention

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

Time frame:
Within 2 seconds after catheter withdrawal.
Reported as:
Mean · Βreaths per minute
Respiratory Rate Immediately After Intervention
Βreaths per minuteCatheter TiemannSuction Catheter
Respiratory Rate Immediately After Intervention26.37 ± 7.54425.79 ± 7.941
SecondaryHeart Rate Immediately After Intervention

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

Time frame:
Within 2 seconds after catheter withdrawal.
Reported as:
Mean · Βeats per minute
Heart Rate Immediately After Intervention
Βeats per minuteCatheter TiemannSuction Catheter
Heart Rate Immediately After Intervention87.21 ± 15.62386.53 ± 14.013
SecondarySystolic Blood Pressure Immediately After Each Intervention

Immediately after each intervention recorded the systolic blood pressure (mmHg).

Time frame:
Within 2 seconds after catheter withdrawal.
Reported as:
Mean · mmHg
Systolic Blood Pressure Immediately After Each Intervention
mmHgCatheter TiemannSuction Catheter
Systolic Blood Pressure Immediately After Each Intervention143.37 ± 24.703141.32 ± 19.136
SecondaryDiastolic Blood Pressure Immediately After Each Intervention

Immediately after each intervention recorded the diastolic blood pressure (mmHg).

Time frame:
Within 2 seconds after catheter withdrawal.
Reported as:
Mean · mmHg
Diastolic Blood Pressure Immediately After Each Intervention
mmHgCatheter TiemannSuction Catheter
Diastolic Blood Pressure Immediately After Each Intervention62.74 ± 13.48260.32 ± 11.856
SecondaryPresence 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.
Reported as:
Number · Catheters with presence of blood
Presence of Blood on Catheter Immediately After Each Intervention
Catheters with presence of bloodCatheter TiemannSuction Catheter
Presence of Blood on Catheter Immediately After Each Intervention66

Adverse events

Collected over 5 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Catheter Tiemann—0/20 (0%)6/20 (30%)
Suction Catheter—0/20 (0%)6/20 (30%)
Most frequent other events
Most frequent other events
EventCatheter TiemannSuction Catheter
Presence of Blood on CatheterInjury, poisoning and procedural complications6/206/20

Baseline characteristics

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
Age, Customized(participants)Catheter Tiemann First, Then Suction CatheterSuction Catheter First, Then Catheter TiemannTotal
<60 years101
60-69 years224
70-79 years336
>80 years459
Sex: Female, Male
Sex: Female, Male(Participants)Catheter Tiemann First, Then Suction CatheterSuction Catheter First, Then Catheter TiemannTotal
Female5510
Male5510
SOFA
SOFA(participants)Catheter Tiemann First, Then Suction CatheterSuction Catheter First, Then Catheter TiemannTotal
<47714
6224
9112
Hospitalisation day
Hospitalisation day(participants)Catheter Tiemann First, Then Suction CatheterSuction Catheter First, Then Catheter TiemannTotal
< 5 days224
≥ 5 days, < 10 days336
≥ 10 days5510
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Pode D, Manny J. A simplified method for repeated nasotracheal suction. Surg Gynecol Obstet. 1984 Aug;159(2):173-4. PubMed 6463830 ↗
  • Brucia J, Rudy E. The effect of suction catheter insertion and tracheal stimulation in adults with severe brain injury. Heart Lung. 1996 Jul-Aug;25(4):295-303. doi: 10.1016/s0147-9563(96)80065-3. PubMed 8836745 ↗
  • Gemma M, Tommasino C, Cerri M, Giannotti A, Piazzi B, Borghi T. Intracranial effects of endotracheal suctioning in the acute phase of head injury. J Neurosurg Anesthesiol. 2002 Jan;14(1):50-4. doi: 10.1097/00008506-200201000-00010. PubMed 11773824 ↗
  • Marlow TJ, Goltra DD Jr, Schabel SI. Intracranial placement of a nasotracheal tube after facial fracture: a rare complication. J Emerg Med. 1997 Mar-Apr;15(2):187-91. doi: 10.1016/s0736-4679(96)00356-3. PubMed 9144060 ↗
  • Sloan EP, VanRooyen MJ. Suction catheter-assisted nasotracheal intubation. Acad Emerg Med. 1994 Jul-Aug;1(4):388-90. doi: 10.1111/j.1553-2712.1994.tb02651.x. PubMed 7614287 ↗
  • Roppolo LP, Vilke GM, Chan TC, Krishel S, Hayden SR, Rosen P, Trione M. Nasotracheal intubation in the emergency department, revisited. J Emerg Med. 1999 Sep-Oct;17(5):791-9. doi: 10.1016/s0736-4679(99)00085-2. PubMed 10499691 ↗
  • Saissy JM, Boussignac G, Cheptel E, Rouvin B, Fontaine D, Bargues L, Levecque JP, Michel A, Brochard L. Efficacy of continuous insufflation of oxygen combined with active cardiac compression-decompression during out-of-hospital cardiorespiratory arrest. Anesthesiology. 2000 Jun;92(6):1523-30. doi: 10.1097/00000542-200006000-00007. PubMed 10839900 ↗
  • Grigoriadis KEpsilon, Angouras DC, Flevari A, Xathos T. Comparison of the Feasibility and Safety of Nasotracheal Suctioning With Curved Edge Catheter Versus Conventional Suction Catheter in Critically Ill Subjects: A Prospective Randomized Crossover Trial. Respir Care. 2015 Dec;60(12):1826-33. doi: 10.4187/respcare.03875. Epub 2015 Oct 20. PubMed 26487746 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02261428
Lead sponsor
Grigoriadis Konstantinos
Responsible party
Grigoriadis Konstantinos (Physical Therapist, Attikon Hospital) — Sponsor-investigator
First posted
Oct 10, 2014
Start date
May 2014
Primary completion
Sep 2014
Completion
Sep 2014
Results posted
Mar 17, 2015
Last update
Mar 17, 2015

Study contacts

Dimitrios Angouras, MD
study director · Athens University School of Medicine, Department of Cardiothoracic Surgery
Theodoros Xanthos, MD
study director · Athens University School of Medicine, Postgraduate program in CPR (moderator)
Konstantinos Grigoriadis, PT
principal investigator · Attikon Hospital
Katerina Flevari, MD
study chair · Attikon Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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