Trial Outcomes & Findings for Nasotracheal Suction With Tiemann Catheter Compared to the Classic Technique With the Suction Catheter (NCT NCT02261428)
NCT ID: NCT02261428
Last Updated: 2015-03-17
Results Overview
We count the required attempts to insert catheter into trachea (number of attempts)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
An average of 15 seconds
Results posted on
2015-03-17
Participant Flow
All ICU patients were breathing spontaneously, had respiratory failure of various pathophysiological mechanisms, with impaired cough reflex
Of the 30 patients screened during the run-in period between May 2014 and September 2014 they received nasotracheal suction all. 10 of them required for pilot study and 20 for the main study. The pilot study was designated as a separate study and the participants was not included in this record.
Participant milestones
| Measure |
Catheter Tiemann First, Then Suction Catheter
Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
|
Suction Catheter First, Then Catheter Tiemann
Participants first received nasotracheal suction with suction catheter. After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nasotracheal Suction With Tiemann Catheter Compared to the Classic Technique With the Suction Catheter
Baseline characteristics by cohort
| Measure |
Catheter Tiemann First, Then Suction Catheter
n=10 Participants
Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
|
Suction Catheter First, Then Catheter Tiemann
n=10 Participants
Participants first received nasotracheal suction with Suction catheter . After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>80 years
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Age, Customized
<60 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
SOFA
<4
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
SOFA
6
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
SOFA
9
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Hospitalisation day
< 5 days
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Hospitalisation day
≥ 5 days, < 10 days
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Hospitalisation day
≥ 10 days
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: An average of 15 secondsWe count the required attempts to insert catheter into trachea (number of attempts)
Outcome measures
| Measure |
Catheter Tiemann
n=19 Participants
The number below represents the mean of attempts made wth catheter Tiemann.
|
Suction Catheter
n=19 Participants
The number below represents the mean of attempts made wth Suction catheter.
|
|---|---|---|
|
Number of Attempts Before Entering Trachea
|
2.63 Attempts
Standard Deviation 2.24
|
6.79 Attempts
Standard Deviation 3.75
|
SECONDARY outcome
Timeframe: An average of 15 secondsPopulation: The 19 interventions with each catheter was used randomly
We count the required time needed to insert catheter into trachea (seconds).
Outcome measures
| Measure |
Catheter Tiemann
n=19 Participants
The number below represents the mean of attempts made wth catheter Tiemann.
|
Suction Catheter
n=19 Participants
The number below represents the mean of attempts made wth Suction catheter.
|
|---|---|---|
|
Time to Entering Trachea
|
10.05 Sec
Standard Deviation 10.074
|
20.06 Sec
Standard Deviation 12.694
|
SECONDARY outcome
Timeframe: Within 2 seconds after catheter withdrawal.Recorded the respiratory rate (breaths per minute), immediately after intervention
Outcome measures
| Measure |
Catheter Tiemann
n=19 Participants
The number below represents the mean of attempts made wth catheter Tiemann.
|
Suction Catheter
n=19 Participants
The number below represents the mean of attempts made wth Suction catheter.
|
|---|---|---|
|
Respiratory Rate Immediately After Intervention
|
26.37 Βreaths per minute
Standard Deviation 7.544
|
25.79 Βreaths per minute
Standard Deviation 7.941
|
SECONDARY outcome
Timeframe: Within 2 seconds after catheter withdrawal.Immediately after each intervention recorded the heart rate (beats per minute).
Outcome measures
| Measure |
Catheter Tiemann
n=19 Participants
The number below represents the mean of attempts made wth catheter Tiemann.
|
Suction Catheter
n=19 Participants
The number below represents the mean of attempts made wth Suction catheter.
|
|---|---|---|
|
Heart Rate Immediately After Intervention
|
87.21 Βeats per minute
Standard Deviation 15.623
|
86.53 Βeats per minute
Standard Deviation 14.013
|
SECONDARY outcome
Timeframe: Within 2 seconds after catheter withdrawal.Immediately after each intervention recorded the systolic blood pressure (mmHg).
Outcome measures
| Measure |
Catheter Tiemann
n=19 Participants
The number below represents the mean of attempts made wth catheter Tiemann.
|
Suction Catheter
n=19 Participants
The number below represents the mean of attempts made wth Suction catheter.
|
|---|---|---|
|
Systolic Blood Pressure Immediately After Each Intervention
|
143.37 mmHg
Standard Deviation 24.703
|
141.32 mmHg
Standard Deviation 19.136
|
SECONDARY outcome
Timeframe: Within 2 seconds after catheter withdrawal.Immediately after each intervention recorded the diastolic blood pressure (mmHg).
Outcome measures
| Measure |
Catheter Tiemann
n=19 Participants
The number below represents the mean of attempts made wth catheter Tiemann.
|
Suction Catheter
n=19 Participants
The number below represents the mean of attempts made wth Suction catheter.
|
|---|---|---|
|
Diastolic Blood Pressure Immediately After Each Intervention
|
62.74 mmHg
Standard Deviation 13.482
|
60.32 mmHg
Standard Deviation 11.856
|
SECONDARY outcome
Timeframe: Within 2 seconds after catheter withdrawal.Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).
Outcome measures
| Measure |
Catheter Tiemann
n=19 Participants
The number below represents the mean of attempts made wth catheter Tiemann.
|
Suction Catheter
n=19 Participants
The number below represents the mean of attempts made wth Suction catheter.
|
|---|---|---|
|
Presence of Blood on Catheter Immediately After Each Intervention
|
6 Catheters with presence of blood
|
6 Catheters with presence of blood
|
Adverse Events
Catheter Tiemann
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Suction Catheter
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Catheter Tiemann
n=20 participants at risk
Participants received nasotracheal suction with catheter Tiemann.
|
Suction Catheter
n=20 participants at risk
Participants received nasotracheal suction with Suction catheter
|
|---|---|---|
|
Injury, poisoning and procedural complications
Presence of Blood on Catheter
|
30.0%
6/20 • Number of events 6 • 5 months
Presence of Blood on Catheter
|
30.0%
6/20 • Number of events 6 • 5 months
Presence of Blood on Catheter
|
Additional Information
Mr. Konstantinos Grigoriadis ICU Physical Therapist
"Attikon" General University Hospital of Athens
Phone: 00302105832489
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place