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
About this trial
This is an interventional supportive care trial for Muscle Weakness focused on measuring Nasotracheal suction, tracheal access
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
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
NCT ID
NCT02261428
First Posted
September 30, 2014
Last Updated
March 15, 2015
Sponsor
Grigoriadis Konstantinos
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
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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
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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
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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
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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
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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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