Lung DiseasesNCT03062137
Finding the Optimal Location for Saturation Measurement During Flexible Bronchoscopy
An observational study of Lung Diseases and Desaturation of Blood, run by Rabin Medical Center at 1 site in Israel.
Trial summary
An observational comparison of different locations of saturation measurements during Flexible Bronchoscopy Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Diseases, Desaturation of Blood
- What is being tested?
- blood gas sampling
- How many people
- 116 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2017to 30 Mar 2017
- Phase
- Observational
- 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 100 years
- All sexes
- Adult, Older adult
Study population: 100 patients, adults, undergoing Flexible Fiberoptic Bronchoscopy under sedation
Who may be able to join
- informed consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Location of Saturation Measurement During Flexible Fiberoptic Bronchoscopy
An observational comparison of different locations of saturation measurements during Flexible Bronchoscopy
Read the detailed description
The study group will include 100 patients undergoing flexible fiberoptic bronchoscopy (FFB).
The patients will receive sedation with Midazolam, Fentanyl and Propofol. All patients will receive supplemental oxygen via nasal cannula (2-4 L/min) before the beginning of the procedure.
In all cases, patients will be monitored using continuous electrocardiography, pulse oximetry (on patients finger), and transcutaneous carbon dioxide and saturation (on patients earlobe), and automated noninvasive blood pressure recordings every 5 minutes. All parameters will be recorded from accepting patient to bed of procedure until 10 minutes after removal of FFB from nasopharynx.
The saturation will be measured in 3 different locations (one pulse is added in other earlobe). additionally, A blood gas sample will be taken during discrepancy between different measurements.
Immediately after the end of procedure, the measurements from 3 different monitors will be printed, and the blood sample be taken to a gas sample machine by the investigator.
Desaturation value and time will be compared between the different locations. The blood arterial saturation will be compared to other measurements taken at the same time.
- Conditions
- Lung Diseases, Desaturation of Blood
- Being tested
- blood gas sampling
- Keywords
- bronchoscopy, saturation
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood gas samplingDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Value changes between locations
Difference of 10% of blood saturation between different locations during sedation for bronchoscopy procedure.
Measured: Through completion of bronchoscopy procedure an average of 30 minutes
Time changes between locations
The level of desaturation of 90% is checked in the different monitors and the gap in seconds is registered
Measured: Through completion of bronchoscopy procedure an average of 30 minutes
Secondary outcomes (1)
gap between arterial gas sample and different monitors
during differences of more than 5% between finger and earlobe monitors we will take an arterial blood sample and the lab result will be compared to the measurements at the same time
Measured: Through completion of bronchoscopy procedure an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Jan 2017
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mordechai Kremer, Rabin Medical Center
- Investigators
- Mordechai R Kramer, MD, Principal investigator, Rabin Medical Center, Belinson Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062137
- Sponsor's protocol ID
- RMC17001ctl
- Status last verified
- Mar 2017
- First submitted
- 31 Jan 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Location of Saturation Measurement During Flexible Fiberoptic Bronchoscopy
- ClinicalTrials.gov ID
- NCT03062137
- Acronym / sponsor ID
- RMC17001ctl
- Conditions
- Lung Diseases, Desaturation of Blood
- Keywords
- bronchoscopy, saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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.
An observational comparison of different locations of saturation measurements during Flexible Bronchoscopy
Detailed description
The study group will include 100 patients undergoing flexible fiberoptic bronchoscopy (FFB).
The patients will receive sedation with Midazolam, Fentanyl and Propofol. All patients will receive supplemental oxygen via nasal cannula (2-4 L/min) before the beginning of the procedure.
In all cases, patients will be monitored using continuous electrocardiography, pulse oximetry (on patients finger), and transcutaneous carbon dioxide and saturation (on patients earlobe), and automated noninvasive blood pressure recordings every 5 minutes. All parameters will be recorded from accepting patient to bed of procedure until 10 minutes after removal of FFB from nasopharynx.
The saturation will be measured in 3 different locations (one pulse is added in other earlobe). additionally, A blood gas sample will be taken during discrepancy between different measurements.
Immediately after the end of procedure, the measurements from 3 different monitors will be printed, and the blood sample be taken to a gas sample machine by the investigator.
Desaturation value and time will be compared between the different locations. The blood arterial saturation will be compared to other measurements taken at the same time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 100 patients, adults, undergoing Flexible Fiberoptic Bronchoscopy under sedation
Key inclusion criteria (1 listed)
- informed consent
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| blood gas sampling | Diagnostic test | – |
Primary outcome
Value changes between locations
Time frame: Through completion of bronchoscopy procedure an average of 30 minutes
Difference of 10% of blood saturation between different locations during sedation for bronchoscopy procedure.
Time changes between locations
Time frame: Through completion of bronchoscopy procedure an average of 30 minutes
The level of desaturation of 90% is checked in the different monitors and the gap in seconds is registered
1 secondary outcome
gap between arterial gas sample and different monitors
Time frame: Through completion of bronchoscopy procedure an average of 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- 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.
Mordechai R Kramer, MD principal investigator
Rabin Medical Center, Belinson Hospital
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 Lung Diseases and Desaturation of Blood, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 31 Mar 2017. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Value changes between locations (time frame: Through completion of bronchoscopy procedure an average of 30 minutes). 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?
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 31 Mar 2017.