Complication of Transplanted LungNCT00584077
Assessment of Cough Reflex in Lung Transplant Recipients
An observational study of Complication of Transplanted Lung, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the presence of cough reflex in the transplanted lung of patients who have had either a single or double lung transplant or heart-lung transplant at University of Texas Medical Branch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Transplanted Lung
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Oct 2007
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single or double lung or heart-lung transplant recipients
Who may be able to join
- Lung transplant recipient
- Hemodynamically stable
- Capable of undergoing bronchoscopy
Who cannot join
- Pneumonia
- Hypoxemia (PaO2 < 70)
- Hemodynamic instability
- Coagulopathy
- Thrombocytopenia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
The purpose of this study is to evaluate the presence of cough reflex in the transplanted lung of patients who have had either a single or double lung transplant or heart-lung transplant at University of Texas Medical Branch. At the 1 year post transplant bronchoscopy, the presence of the cough reflex will be assessed by placing 3 to 5 ml of 5% dextrose and placement of the bronchial biopsy forceps on the airway mucosa. Three to four separate areas of the transplanted airways will be assessed. The cough reflex will be assessed by recording the surface electrical activity by placing external electrodes to monitor the movement of abdominal muscles during a cough. The data will be recorded and compared with recordings from coughs recorded using the surface electrical activity of a cough generated by non-transplant patients.
Read the detailed description
Bronchoscopy Stable, lung transplant recipients undergoing surveillance bronchoscopy will be enrolled. We will exclude subjects with new or persistent cough, hypoxemia, new radiographic infiltrates, or hemodynamic instability.
Before bronchoscopy, patients will receive diazepam while codeine and atropine will be withheld. Upper airway anesthesia was performed using cotton swabs soaked with 4 % lidocaine applied on the oropharyngeal mucosa and gradually placed posteriorly with the aid of curved foreceps to anesthetize the supraglottic region. A trained individual will perform topical upper airway anesthesia over 15 minutes and adequate anesthesia will be determined once subjects fail to cough during foreceps application to the supraglottic region. Conscious sedation will be administered using intravenous midazolam while vital signs are monitored. Once adequate sedation is achieved, the bronchoscope will be introduced through the mouth beyond the vocal chords to the main carina and slowly advanced to the airway anastomosis. Coughing that occurs with advancement of the bronchoscope from the chords to the anastomosis will be addressed by maintaining the bronchoscope in an immobile neutral position for 60-180 seconds until coughing stops and the cough provocation will be performed.
Cough provocation Airway irritants will be applied in the following sequence: 1) one cm distal to anastomosis, 2) one cm proximal to anastomosis and 3) at the main carina. Chemical irritation will consist of 3 mL aliquots of 5 % dextrose water (D5W) instilled through the bronchoscope channel on the bronchial mucosa (21). Aliquots of D5W will be administered at each site on three separate occasions with a 60 second interval between administrations. Mechanical irritation will involve placement of the biopsy foreceps on the bronchial mucosa at each site. The sequence of airway irritation sites will always begin with the distal anastomosis followed by the proximal anastomosis and main carina.
Airway lidocaine administration Patients demonstrating a cough reflex at the distal anastomotic site will be recorded. After measurements are obtained at all airway sites, the bronchoscope will be reintroduced to the distal anastomosis and 3 mL of 4 % lidocaine instilled on the bronchial mucosa. Sixty seconds later, mechanical and chemical irritation of the proximal and distal anastomosis will be performed as previously outlined.
Cough assessment Cough frequency will be determined by counting audible coughs and abdominal muscle contractions measured with a surface electromyograph (EMG) recorder. Surface electrodes placed on the skin, 2 cm below each costal margin along the midclavicular line will be connected to an EMG recorder (Biopac Systems Inc, Santa Barbara, CA) linked to a dedicated computer. Continuous EMG recordings will be obtained 15 seconds before administration of the airway irritant to ensure absence of cough before airway irritant administration (Figure 1). Twenty seconds or more of recording will be obtained after airway irritant application. Cough will be defined as abdominal muscle contraction and audible expiratory sound.
- Conditions
- Complication of Transplanted Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stable lung transplant recipients | All enrolled subjects receive the same procedures; bronchoscopy with administration of mechanical and chemical irritants to the airway mucosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Coughs
The number of coughs elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (D5W) at the level of the main carina, proximal to airway anastomosis (native airway) and distal to the airway anastomosis (allograft airway).
Measured: 15-20 minutes
Secondary outcomes (1)
to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year
Presence of cough as elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (dextrose solution) at the level of the main carina, native lung airway and proximal and distal to the airway anastomosis. Lung transplant recipients underwent airway evaluations using the above protocel at 1.5 and 12 months after lung transplantation.
after undergoing transplantation
Measured: 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startApr 2000
- Primary completionOct 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of Transplanted LungStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander G Duarte, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584077
- Sponsor's protocol ID
- 00-132
- Status last verified
- Feb 2018
- First submitted
- 20 Dec 2007
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Duarte AG, Terminella L, Smith JT, Myers AC, Campbell G, Lick S. Restoration of cough reflex in lung transplant recipients. Chest. 2008 Aug;134(2):310-316. doi: 10.1378/chest.07-2934. Epub 2008 Mar 13.
PubMed 18339778
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cough Reflex in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT00584077
- Acronym / sponsor ID
- 00-132
- Conditions
- Complication of Transplanted Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Apr 2000
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Posted 25 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the presence of cough reflex in the transplanted lung of patients who have had either a single or double lung transplant or heart-lung transplant at University of Texas Medical Branch. At the 1 year post transplant bronchoscopy, the presence of the cough reflex will be assessed by placing 3 to 5 ml of 5% dextrose and placement of the bronchial biopsy forceps on the airway mucosa. Three to four separate areas of the transplanted airways will be assessed. The cough reflex will be assessed by recording the surface electrical activity by placing external electrodes to monitor the movement of abdominal muscles during a cough. The data will be recorded and compared with recordings from coughs recorded using the surface electrical activity of a cough generated by non-transplant patients.
Detailed description
Bronchoscopy Stable, lung transplant recipients undergoing surveillance bronchoscopy will be enrolled. We will exclude subjects with new or persistent cough, hypoxemia, new radiographic infiltrates, or hemodynamic instability.
Before bronchoscopy, patients will receive diazepam while codeine and atropine will be withheld. Upper airway anesthesia was performed using cotton swabs soaked with 4 % lidocaine applied on the oropharyngeal mucosa and gradually placed posteriorly with the aid of curved foreceps to anesthetize the supraglottic region. A trained individual will perform topical upper airway anesthesia over 15 minutes and adequate anesthesia will be determined once subjects fail to cough during foreceps application to the supraglottic region. Conscious sedation will be administered using intravenous midazolam while vital signs are monitored. Once adequate sedation is achieved, the bronchoscope will be introduced through the mouth beyond the vocal chords to the main carina and slowly advanced to the airway anastomosis. Coughing that occurs with advancement of the bronchoscope from the chords to the anastomosis will be addressed by maintaining the bronchoscope in an immobile neutral position for 60-180 seconds until coughing stops and the cough provocation will be performed.
Cough provocation Airway irritants will be applied in the following sequence: 1) one cm distal to anastomosis, 2) one cm proximal to anastomosis and 3) at the main carina. Chemical irritation will consist of 3 mL aliquots of 5 % dextrose water (D5W) instilled through the bronchoscope channel on the bronchial mucosa (21). Aliquots of D5W will be administered at each site on three separate occasions with a 60 second interval between administrations. Mechanical irritation will involve placement of the biopsy foreceps on the bronchial mucosa at each site. The sequence of airway irritation sites will always begin with the distal anastomosis followed by the proximal anastomosis and main carina.
Airway lidocaine administration Patients demonstrating a cough reflex at the distal anastomotic site will be recorded. After measurements are obtained at all airway sites, the bronchoscope will be reintroduced to the distal anastomosis and 3 mL of 4 % lidocaine instilled on the bronchial mucosa. Sixty seconds later, mechanical and chemical irritation of the proximal and distal anastomosis will be performed as previously outlined.
Cough assessment Cough frequency will be determined by counting audible coughs and abdominal muscle contractions measured with a surface electromyograph (EMG) recorder. Surface electrodes placed on the skin, 2 cm below each costal margin along the midclavicular line will be connected to an EMG recorder (Biopac Systems Inc, Santa Barbara, CA) linked to a dedicated computer. Continuous EMG recordings will be obtained 15 seconds before administration of the airway irritant to ensure absence of cough before airway irritant administration (Figure 1). Twenty seconds or more of recording will be obtained after airway irritant application. Cough will be defined as abdominal muscle contraction and audible expiratory sound.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable lung transplant recipients | – | –All enrolled subjects receive the same procedures; bronchoscopy with administration of mechanical and chemical irritants to the airway mucosa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single or double lung or heart-lung transplant recipients
Key inclusion criteria (3 listed)
- Lung transplant recipient
- Hemodynamically stable
- Capable of undergoing bronchoscopy
Key exclusion criteria (5 listed)
- Pneumonia
- Hypoxemia (PaO2 < 70)
- Hemodynamic instability
- Coagulopathy
- Thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Coughs
Time frame: 15-20 minutes
The number of coughs elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (D5W) at the level of the main carina, proximal to airway anastomosis (native airway) and distal to the airway anastomosis (allograft airway).
1 secondary outcome
to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year
Time frame: 15-20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18339778Duarte AG, Terminella L, Smith JT, Myers AC, Campbell G, Lick S. Restoration of cough reflex in lung transplant recipients. Chest. 2008 Aug;134(2):310-316. doi: 10.1378/chest.07-2934. Epub 2008 Mar 13.
- Individual participant dataSharing planned: No
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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.
Alexander G Duarte, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Transplanted Lung, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 2 Nov 2018. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Coughs (time frame: 15-20 minutes). 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 NCT00584077, which also lists 1 linked publication.
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 2 Nov 2018.