Clinical trial NCT02261428: Nasotracheal Suction With Tiemann Catheter Compared to the Classic Technique With the Suction Catheter
Official title: Randomized Controlled Study of Nasotracheal Suction With Tiemann Catheter Compared to the Classic Technique With the Standard One.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Keywords: Nasotracheal suction, tracheal access
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 "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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Attempts Before Entering Trachea
timeFrame: An average of 15 seconds
Secondary outcomes:
measure: Time to Entering Trachea
timeFrame: An average of 15 seconds
measure: Respiratory Rate Immediately After Intervention
timeFrame: Within 2 seconds after catheter withdrawal.
measure: Heart Rate Immediately After Intervention
timeFrame: Within 2 seconds after catheter withdrawal.
measure: Systolic Blood Pressure Immediately After Each Intervention
timeFrame: Within 2 seconds after catheter withdrawal.
measure: Diastolic Blood Pressure Immediately After Each Intervention
timeFrame: Within 2 seconds after catheter withdrawal.
measure: Presence of Blood on Catheter Immediately After Each Intervention
timeFrame: Within 2 seconds after catheter withdrawal.
Other outcomes:
Locations:
Study officials:
affiliation: Athens University School of Medicine, Department of Cardiothoracic Surgery
name: Dimitrios Angouras, MD
role: STUDY_DIRECTOR
affiliation: Athens University School of Medicine, Postgraduate program in CPR (moderator)
name: Theodoros Xanthos, MD
role: STUDY_DIRECTOR
affiliation: Attikon Hospital
name: Konstantinos Grigoriadis, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Attikon Hospital
name: Katerina Flevari, MD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.