Ineffective Airway ClearancePhase 1NCT02116491
Visual Sputum Suctioning System Tests in Mechanically Ventilated Patients
A Phase 1 study testing Visual Sputum Suctioning System in people with Ineffective Airway Clearance and Respiratory Tract Hemorrhage, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
BACKGROUND: The investigators developed a fiber-optic-guided endotracheal suction catheter (visual sputum suctioning system or VSSS), which the investigators previously tested in vitro and animals. It integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen catheter. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ineffective Airway Clearance, Respiratory Tract Hemorrhage
- What is being tested?
- Visual Sputum Suctioning System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to RICU
- 18 years old or more
- Ventilated more than 24 hours mechanical ventilation
- Patients with stability (MAP>70 mmHg, HR<130 b/min)
- Signed informed consent
Who cannot join
- Current or past participation in another intervention trial conflicting with the present study patients with stupor and coma
- Any clinical events or practitioner interventions within 15 min prior to study enrollment (eg, a change in ventilator settings, hemodynamic instability [DBP >100 mmHg; ↑or 20mmHg in PaO2; ↑20 b/min in HR]; sever hypoxemia [SpO2<85%, PaO2<50mmHg])
- Had heart or lung or heart transplantation.
- Had massive hemoptysis.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gerontology, First Affiliated Hospital of Chongqing Medical University,
Chongqing, Chongqing Municipality, 400016
Jinxing Wu, PhD, Pro, (86) 23-89012962, 639wjx@sina.com
Bingbing Yan, MD
About this study
Official title: Test of a Novel Visual Sputum Suctioning System in Mechanically Ventilated Patients
BACKGROUND: The investigators developed a fiber-optic-guided endotracheal suction catheter (visual sputum suctioning system or VSSS), which the investigators previously tested in vitro and animals. It integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen catheter.
PURPOSE: The purpose of this study was to investigate the safety and efficacy of sputum suctioning system in mechanical ventilated patients in respiratory intensive care unit (RICU). The investigators compare the weight of secretions collected, vital signs, and tracheal wall injury between two groups of patients randomized to have VSSS combined with closed system suction (CSC) suction and patients having CSC suction alone.
HYPOTHESIS: The investigators theorized that the VSSS collected more sputum and caused less change of vital signs than conventional CSC.
Read the detailed description
Study design: This is a randomized controlled trial study, including patients ventilated in one respiratory intensive care unit (RICU). Two suction systems (The novel VSSS and conventional CSS alone) will be compared at time point before (baseline), immediately after, 3 min after, and 5 min after suctioning.
Background: Sputum suctioning is a routine clinical procedure that is crucial for keeping the airway open, to reduce the incidence of respiratory-tract infections. In most circumstances, a conventional catheter with a single-lumen channel is used for sputum suctioning. However, this procedure Involves blind manipulation of the catheter on the part of the clinician and thus depends largely on the clinician's skills and experience. Therefore, complications occur in some patients, especially on the changes of the parameters of the heart-lung system. In addition, because clinicians cannot directly target sputum in the trachea, the efficiency of the procedure may be reduced.
Recently, a visual sputum suctioning system (VSSS) was developed in our research group. It integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen catheter.
In vitro tests investigators found that the ability to visualize the airway allows targeting of sputum, which compensates for the smaller lumen and makes the suctioning procedure more efficient overall. In addition, in animal tests investigators found that the VSSS collected more sputum and caused less tracheal mucosa damage than conventional suctioning.
Purpose: The present study investigated the safety and efficacy of sputum suctioning system with this double-lumen catheter in mechanical ventilated patients in respiratory intensive care unit (RICU). The purpose of this study was to compare the weight of secretions collected, vital signs, and tracheal wall injury between two groups of patients randomized to have VSSS combined with closed system suction (CSC) suction and patients having CSC suction alone. investigators theorized that the VSSS collected more sputum and caused less change of vital signs than conventional CSC.
Registry procedure: All requested information will be recorded on case report forms and explanation will be reported for any missing data. False data will be clearly corrected, and signed by investigator or authorized person.
Monitoring will be realized by the co-investigator in association with the clinical research associate.
Sample size assessment: Number of subjects: 40 patients. Three months should be necessary to include these patients.
Statistical analysis: Investigators determined that 20 patients per group would provide a power of 95%, with a α level of 5%.
Results will be expressed as means ± Standard Deviation. SPSS 10.0 (Chicago, Illinois, USA) for the statistical calculation was used. P values < 0.05 were considered statistically significant. Investigators used the nonparametric t test for normally distributed data, and the nonparametric Wilcoxon-Mann-Whitney rank test for other data.Investigators used repeated-measures analysis of variance at four time points (before suctioning, immediately after suctioning, 3 min after suctioning, and 5 min after suctioning) to analyze changes and differences in PaO2, heart rate, and mean arterial pressure.
- Being tested
- Visual Sputum Suctioning System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Sputum Suctioning SystemDevice
Also called VSSS
All ES procedures were performed on indication by RICU nurses and according to protocol, according to which Closed suction system was performed which the patient remained connected to the ventilator. The double-lumen catheter of the Visual Sputum Suctioning System integrated with a 0.9-mm micro-imaging fiber was inserted into the endotracheal tube until resistance was met and withdrawn 0.5 cm. A negative pressure of maximum 150mmHg was set, and the catheter was withdrawn while gently rotating. The procedure lasted for a total of 10 seconds. Nonsterile gloves were to be used during all procedures.
| Study group | Role | What they receive |
|---|---|---|
| Closed suction system | No intervention | All ES procedures were performed on indication by RICU nurses and according to protocol, according to which Cloesd suction system was performed which the patient remained connected to the ventilator. The catheter was inserted into the endotracheal tube until resistance was met and withdrawn 0.5 cm. A negative pressure of maximum 150mmHg was set, and the catheter was withdrawn while gently rotating. The procedure lasted for a total of 10 seconds. Nonsterile gloves were to be used during all procedures. |
| Visual Sputum Suctioning System | Experimental | All ES procedures were performed on indication by RICU nurses and according to protocol, according to which Closed suction system was performed which the patient remained connected to the ventilator. The double-lumen catheter of the Visual Sputum Suctioning System integrated with a 0.9-mm micro-imaging fiber was inserted into the endotracheal tube until resistance was met and withdrawn 0.5 cm. A negative pressure of maximum 150mmHg was set, and the catheter was withdrawn while gently rotating. The procedure lasted for a total of 10 seconds. Nonsterile gloves were to be used during all procedures. Receives: Device: Visual Sputum Suctioning System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in hemodynamic and respiratory data at 5 min
The hemodynamic and respiratory data including heart rate, arterial partial pressure of oxygen and mean arterial pressure will be recorded before (baseline), immediately after, 3 min after, and 5 min after suctioning.
Measured: Patients will be followed until 2 hour after suction.
Rate of hemorrhage
Measured: Patients will be followed until 2 hour after suction.
Secondary outcomes (1)
Weight gain of the suction catheter
Weight gain of the suction catheter due to secretions will be measured by mean of a high precision laboratory scale.
Measured: Until finished suctioning (An expected average of 10 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ineffective Airway ClearanceStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinxing Wu, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Jinxing Wu, PhD, Pro, Study chair, Department of Respiratory Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116491
- Sponsor's protocol ID
- JWu
- Status last verified
- Apr 2014
- First submitted
- 12 Apr 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi JS, Jones AY. Effects of manual hyperinflation and suctioning in respiratory mechanics in mechanically ventilated patients with ventilator-associated pneumonia. Aust J Physiother. 2005;51(1):25-30. doi: 10.1016/s0004-9514(05)70050-7.
PubMed 15748122Yorioka K, Oie S, Kamiya A. Microbial contamination of suction tubes attached to suction instruments and preventive methods. Jpn J Infect Dis. 2010 Mar;63(2):124-7.
PubMed 20332576Barnes CA, Kirchhoff KT. Minimizing hypoxemia due to endotracheal suctioning: a review of the literature. Heart Lung. 1986 Mar;15(2):164-76. No abstract available.
PubMed 3512492Brochard L, Mion G, Isabey D, Bertrand C, Messadi AA, Mancebo J, Boussignac G, Vasile N, Lemaire F, Harf A. Constant-flow insufflation prevents arterial oxygen desaturation during endotracheal suctioning. Am Rev Respir Dis. 1991 Aug;144(2):395-400. doi: 10.1164/ajrccm/144.2.395.
PubMed 1859066Maggiore SM, Lellouche F, Pigeot J, Taille S, Deye N, Durrmeyer X, Richard JC, Mancebo J, Lemaire F, Brochard L. Prevention of endotracheal suctioning-induced alveolar derecruitment in acute lung injury. Am J Respir Crit Care Med. 2003 May 1;167(9):1215-24. doi: 10.1164/rccm.200203-195OC. Epub 2003 Feb 13.
PubMed 12615633Almgren B, Wickerts CJ, Heinonen E, Hogman M. Side effects of endotracheal suction in pressure- and volume-controlled ventilation. Chest. 2004 Mar;125(3):1077-80. doi: 10.1378/chest.125.3.1077.
PubMed 15006972
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of a Novel Visual Sputum Suctioning System in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT02116491
- Acronym / sponsor ID
- JWu
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: The investigators developed a fiber-optic-guided endotracheal suction catheter (visual sputum suctioning system or VSSS), which the investigators previously tested in vitro and animals. It integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen catheter.
PURPOSE: The purpose of this study was to investigate the safety and efficacy of sputum suctioning system in mechanical ventilated patients in respiratory intensive care unit (RICU). The investigators compare the weight of secretions collected, vital signs, and tracheal wall injury between two groups of patients randomized to have VSSS combined with closed system suction (CSC) suction and patients having CSC suction alone.
HYPOTHESIS: The investigators theorized that the VSSS collected more sputum and caused less change of vital signs than conventional CSC.
Detailed description
Study design: This is a randomized controlled trial study, including patients ventilated in one respiratory intensive care unit (RICU). Two suction systems (The novel VSSS and conventional CSS alone) will be compared at time point before (baseline), immediately after, 3 min after, and 5 min after suctioning.
Background: Sputum suctioning is a routine clinical procedure that is crucial for keeping the airway open, to reduce the incidence of respiratory-tract infections. In most circumstances, a conventional catheter with a single-lumen channel is used for sputum suctioning. However, this procedure Involves blind manipulation of the catheter on the part of the clinician and thus depends largely on the clinician's skills and experience. Therefore, complications occur in some patients, especially on the changes of the parameters of the heart-lung system. In addition, because clinicians cannot directly target sputum in the trachea, the efficiency of the procedure may be reduced.
Recently, a visual sputum suctioning system (VSSS) was developed in our research group. It integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen catheter.
In vitro tests investigators found that the ability to visualize the airway allows targeting of sputum, which compensates for the smaller lumen and makes the suctioning procedure more efficient overall. In addition, in animal tests investigators found that the VSSS collected more sputum and caused less tracheal mucosa damage than conventional suctioning.
Purpose: The present study investigated the safety and efficacy of sputum suctioning system with this double-lumen catheter in mechanical ventilated patients in respiratory intensive care unit (RICU). The purpose of this study was to compare the weight of secretions collected, vital signs, and tracheal wall injury between two groups of patients randomized to have VSSS combined with closed system suction (CSC) suction and patients having CSC suction alone. investigators theorized that the VSSS collected more sputum and caused less change of vital signs than conventional CSC.
Registry procedure: All requested information will be recorded on case report forms and explanation will be reported for any missing data. False data will be clearly corrected, and signed by investigator or authorized person.
Monitoring will be realized by the co-investigator in association with the clinical research associate.
Sample size assessment: Number of subjects: 40 patients. Three months should be necessary to include these patients.
Statistical analysis: Investigators determined that 20 patients per group would provide a power of 95%, with a α level of 5%.
Results will be expressed as means ± Standard Deviation. SPSS 10.0 (Chicago, Illinois, USA) for the statistical calculation was used. P values < 0.05 were considered statistically significant. Investigators used the nonparametric t test for normally distributed data, and the nonparametric Wilcoxon-Mann-Whitney rank test for other data.Investigators used repeated-measures analysis of variance at four time points (before suctioning, immediately after suctioning, 3 min after suctioning, and 5 min after suctioning) to analyze changes and differences in PaO2, heart rate, and mean arterial pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed suction system | No intervention | –All ES procedures were performed on indication by RICU nurses and according to protocol, according to which Cloesd suction system was performed which the patient remained connected to the ventilator. The catheter was inserted into the endotracheal tube until resistance was met and withdrawn 0.5 cm. A negative pressure of maximum 150mmHg was set, and the catheter was withdrawn while gently rotating. The procedure lasted for a total of 10 seconds. Nonsterile gloves were to be used during all procedures. |
| Visual Sputum Suctioning System | Experimental | Device: Visual Sputum Suctioning SystemAll ES procedures were performed on indication by RICU nurses and according to protocol, according to which Closed suction system was performed which the patient remained connected to the ventilator. The double-lumen catheter of the Visual Sputum Suctioning System integrated with a 0.9-mm micro-imaging fiber was inserted into the endotracheal tube until resistance was met and withdrawn 0.5 cm. A negative pressure of maximum 150mmHg was set, and the catheter was withdrawn while gently rotating. The procedure lasted for a total of 10 seconds. Nonsterile gloves were to be used during all procedures. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients admitted to RICU
- 18 years old or more
- Ventilated more than 24 hours mechanical ventilation
- Patients with stability (MAP>70 mmHg, HR<130 b/min)
- Signed informed consent
Key exclusion criteria (5 listed)
- Current or past participation in another intervention trial conflicting with the present study patients with stupor and coma
- Any clinical events or practitioner interventions within 15 min prior to study enrollment (eg, a change in ventilator settings, hemodynamic instability [DBP >100 mmHg; ↑or 20mmHg in PaO2; ↑20 b/min in HR]; sever hypoxemia [SpO2<85%, PaO2<50mmHg])
- Had heart or lung or heart transplantation.
- Had massive hemoptysis.
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Sputum Suctioning SystemAlso: VSSSAll ES procedures were performed on indication by RICU nurses and according to protocol, according to which Closed suction system was performed which the patient remained connected to the ventilator. The double-lumen catheter of the Visual Sputum Suctioning System integrated with a 0.9-mm micro-imaging fiber was inserted into the endotracheal tube until resistance was met and withdrawn 0.5 cm. A negative pressure of maximum 150mmHg was set, and the catheter was withdrawn while gently rotating. The procedure lasted for a total of 10 seconds. Nonsterile gloves were to be used during all procedures. | Device | Visual Sputum Suctioning System |
Primary outcome
Change from Baseline in hemodynamic and respiratory data at 5 min
Time frame: Patients will be followed until 2 hour after suction.
The hemodynamic and respiratory data including heart rate, arterial partial pressure of oxygen and mean arterial pressure will be recorded before (baseline), immediately after, 3 min after, and 5 min after suctioning.
Rate of hemorrhage
Time frame: Patients will be followed until 2 hour after suction.
1 secondary outcome
Weight gain of the suction catheter
Time frame: Until finished suctioning (An expected average of 10 min)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Background: PubMed 15748122Choi JS, Jones AY. Effects of manual hyperinflation and suctioning in respiratory mechanics in mechanically ventilated patients with ventilator-associated pneumonia. Aust J Physiother. 2005;51(1):25-30. doi: 10.1016/s0004-9514(05)70050-7.
- Background: PubMed 20332576Yorioka K, Oie S, Kamiya A. Microbial contamination of suction tubes attached to suction instruments and preventive methods. Jpn J Infect Dis. 2010 Mar;63(2):124-7.
- Background: PubMed 3512492Barnes CA, Kirchhoff KT. Minimizing hypoxemia due to endotracheal suctioning: a review of the literature. Heart Lung. 1986 Mar;15(2):164-76. No abstract available.
- Background: PubMed 1859066Brochard L, Mion G, Isabey D, Bertrand C, Messadi AA, Mancebo J, Boussignac G, Vasile N, Lemaire F, Harf A. Constant-flow insufflation prevents arterial oxygen desaturation during endotracheal suctioning. Am Rev Respir Dis. 1991 Aug;144(2):395-400. doi: 10.1164/ajrccm/144.2.395.
- Background: PubMed 12615633Maggiore SM, Lellouche F, Pigeot J, Taille S, Deye N, Durrmeyer X, Richard JC, Mancebo J, Lemaire F, Brochard L. Prevention of endotracheal suctioning-induced alveolar derecruitment in acute lung injury. Am J Respir Crit Care Med. 2003 May 1;167(9):1215-24. doi: 10.1164/rccm.200203-195OC. Epub 2003 Feb 13.
- Background: PubMed 15006972Almgren B, Wickerts CJ, Heinonen E, Hogman M. Side effects of endotracheal suction in pressure- and volume-controlled ventilation. Chest. 2004 Mar;125(3):1077-80. doi: 10.1378/chest.125.3.1077.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinxing Wu, PhD, Pro study chair
Department of Respiratory Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Visual Sputum Suctioning System in people with Ineffective Airway Clearance and Respiratory Tract Hemorrhage, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xun Liu, MD ((86) -13983239458, liuxunhi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in hemodynamic and respiratory data at 5 min (time frame: Patients will be followed until 2 hour after suction.). The study lists 2 primary outcomes in all. 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 NCT02116491, which also lists 6 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 Apr 2014.