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

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Catheter Tiemann
Suction catheter
Sponsored by
Grigoriadis Konstantinos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscle Weakness focused on measuring Nasotracheal suction, tracheal access

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Catheter Tiemann

    Suction catheter

    Arm Description

    We tested the ability of Tiemman catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention

    We tested the ability of suction catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention

    Outcomes

    Primary Outcome Measures

    Number of Attempts Before Entering Trachea
    We count the required attempts to insert catheter into trachea (number of attempts)

    Secondary Outcome Measures

    Time to Entering Trachea
    We count the required time needed to insert catheter into trachea (seconds).
    Respiratory Rate Immediately After Intervention
    Recorded the respiratory rate (breaths per minute), immediately after intervention
    Heart Rate Immediately After Intervention
    Immediately after each intervention recorded the heart rate (beats per minute).
    Systolic Blood Pressure Immediately After Each Intervention
    Immediately after each intervention recorded the systolic blood pressure (mmHg).
    Diastolic Blood Pressure Immediately After Each Intervention
    Immediately after each intervention recorded the diastolic blood pressure (mmHg).
    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).

    Full Information

    First Posted
    September 30, 2014
    Last Updated
    March 15, 2015
    Sponsor
    Grigoriadis Konstantinos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02261428
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Grigoriadis Konstantinos

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 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). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscle Weakness
    Keywords
    Nasotracheal suction, tracheal access

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Catheter Tiemann
    Arm Type
    Experimental
    Arm Description
    We tested the ability of Tiemman catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention
    Arm Title
    Suction catheter
    Arm Type
    Active Comparator
    Arm Description
    We tested the ability of suction catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention
    Intervention Type
    Device
    Intervention Name(s)
    Catheter Tiemann
    Intervention Description
    We tested the ability of Tiemann catheter to access trachea in order to aspirate bronchial secretions in ICU patients
    Intervention Type
    Device
    Intervention Name(s)
    Suction catheter
    Intervention Description
    We tested the ability of Suction catheter to access trachea in order to aspirate bronchial secretions in ICU patients
    Primary Outcome Measure Information:
    Title
    Number of Attempts Before Entering Trachea
    Description
    We count the required attempts to insert catheter into trachea (number of attempts)
    Time Frame
    An average of 15 seconds
    Secondary Outcome Measure Information:
    Title
    Time to Entering Trachea
    Description
    We count the required time needed to insert catheter into trachea (seconds).
    Time Frame
    An average of 15 seconds
    Title
    Respiratory Rate Immediately After Intervention
    Description
    Recorded the respiratory rate (breaths per minute), immediately after intervention
    Time Frame
    Within 2 seconds after catheter withdrawal.
    Title
    Heart Rate Immediately After Intervention
    Description
    Immediately after each intervention recorded the heart rate (beats per minute).
    Time Frame
    Within 2 seconds after catheter withdrawal.
    Title
    Systolic Blood Pressure Immediately After Each Intervention
    Description
    Immediately after each intervention recorded the systolic blood pressure (mmHg).
    Time Frame
    Within 2 seconds after catheter withdrawal.
    Title
    Diastolic Blood Pressure Immediately After Each Intervention
    Description
    Immediately after each intervention recorded the diastolic blood pressure (mmHg).
    Time Frame
    Within 2 seconds after catheter withdrawal.
    Title
    Presence of Blood on Catheter Immediately After Each Intervention
    Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dimitrios Angouras, MD
    Organizational Affiliation
    Athens University School of Medicine, Department of Cardiothoracic Surgery
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Theodoros Xanthos, MD
    Organizational Affiliation
    Athens University School of Medicine, Postgraduate program in CPR (moderator)
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Konstantinos Grigoriadis, PT
    Organizational Affiliation
    Attikon Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Katerina Flevari, MD
    Organizational Affiliation
    Attikon Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    6463830
    Citation
    Pode D, Manny J. A simplified method for repeated nasotracheal suction. Surg Gynecol Obstet. 1984 Aug;159(2):173-4.
    Results Reference
    background
    PubMed Identifier
    8836745
    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.
    Results Reference
    background
    PubMed Identifier
    11773824
    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.
    Results Reference
    background
    PubMed Identifier
    9144060
    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.
    Results Reference
    background
    PubMed Identifier
    7614287
    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.
    Results Reference
    background
    PubMed Identifier
    10499691
    Citation
    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. Erratum In: J Emerg Med 2000 Jan;18(1):145.
    Results Reference
    background
    PubMed Identifier
    10839900
    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.
    Results Reference
    background
    PubMed Identifier
    26487746
    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.
    Results Reference
    derived

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

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