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Muscle WeaknessNCT02261428

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

A study testing Catheter Tiemann and Suction catheter in people with Muscle Weakness, run by Grigoriadis Konstantinos.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 45 to 85 years
Conditions the study is for
Muscle Weakness
What is being tested?
Catheter Tiemann and Suction catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
May 2014to Sep 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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":

  1. Achieving of the entrance into the nasopharynx b) Achieving of the entrance into the trachea
  2. 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).
  1. 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:

  1. 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:

  1. 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.

Conditions
Muscle Weakness
Being tested
Catheter Tiemann, Suction catheter
Keywords
Nasotracheal suction, tracheal access
Medical subject headings
Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catheter TiemannDevice

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

  • Suction catheterDevice

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

Study groups in NCT02261428
Study groupRoleWhat they receive
Catheter TiemannExperimentalWe tested the ability of Tiemman catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention
Receives: Device: Catheter Tiemann
Suction catheterActive comparatorWe tested the ability of suction catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention
Receives: Device: Suction catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Attempts Before Entering Trachea

    We count the required attempts to insert catheter into trachea (number of attempts)

    Measured: An average of 15 seconds

Secondary outcomes (6)
  1. Time to Entering Trachea

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

    Measured: An average of 15 seconds

  2. Respiratory Rate Immediately After Intervention

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

    Measured: Within 2 seconds after catheter withdrawal.

  3. Heart Rate Immediately After Intervention

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

    Measured: Within 2 seconds after catheter withdrawal.

  4. Systolic Blood Pressure Immediately After Each Intervention

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

    Measured: Within 2 seconds after catheter withdrawal.

  5. Diastolic Blood Pressure Immediately After Each Intervention

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

    Measured: 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).

    Measured: Within 2 seconds after catheter withdrawal.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02261428
Sponsor's protocol ID
AttikonH
Status last verified
Mar 2015
First submitted
30 Sep 2014
Last updated
17 Mar 2015
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing Catheter Tiemann and Suction catheter in people with Muscle Weakness, run by Grigoriadis Konstantinos.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Attempts Before Entering Trachea (time frame: An average of 15 seconds). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02261428, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.

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