Impaired Airway ClearanceNCT01289483
Fospropofol for Sedation During Elective Awake Intubation
A study testing fospropofol in people with Impaired Airway Clearance, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Patients scheduled for awake fiberoptic intubation (AFI) because of potential difficult airway will be consented prior to intubation ASA Physical Status classification and history of difficult intubation will be recorded at screening. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Impaired Airway Clearance
- What is being tested?
- fospropofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 2011
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: between 18-64 years of age
- ASA physical status 1-3 ( Except patients with severe cardiac and/or pulmonary disease
- Weight 60-90 Kg
- Elective surgery requiring awake FOI
- Male or female, female patients should not be pregnant (documented by morning of surgery urine pregnancy test result as per routine hospital policy) or lactating
Who cannot join
- Previous exposure to any experimental drug within 30 days prior to study drug administration
- Raised intracranial pressure
- Patients for whom propofol is contraindicated
- Allergy to midazolam and/or fentanyl
Trial locations and contacts
1 site in 1 country.
About this study
Patients scheduled for awake fiberoptic intubation (AFI) because of potential difficult airway will be consented prior to intubation ASA Physical Status classification and history of difficult intubation will be recorded at screening. The investigators will also record the results of airway examination including Mallampati classification, thyromental distance, mouth opening, neck circumference, neck range of motion, presence or absence of beard and overbite, history of neck radiation, and mandibular protrusion test Informed consent will be obtained prior to the procedure from those patients who meet the inclusion and exclusion criteria.
Standard hemodynamic monitoring will be used in all patients including EKG, blood pressure, heart rate, respiratory rate and oxygen saturation. Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale will be used to assess the level of alertness/sedation. Two consecutive MOAA/S scores of 4 will be considered as the desired effect of moderate sedation.
For AFI procedure, IV will be started and oxygen will be administered. 4 L of oxygen will be delivered through nasal canula until the completion of the AFI procedure. Patient head will be positioned in the sniffing position, Topical anesthesia would be achieved using the topical administration of 4 percent lidocaine using atomized and MaDgic nebulizer, and 2% xylocaine Jel applied to the surface of Williams airway in a total dose of lidocaine not exceeding 10 mg/kg. Patients will be randomized to one of the four fospropofol treatment arms: 2, 3.5, 5, or 6.5 mg/kg
- Conditions
- Impaired Airway Clearance
- Being tested
- fospropofol
- Keywords
- awake fiberoptic intubation (AFI), difficult airway, fospropofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fospropofolDrug
After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
fospropofolDrug
After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
fospropofolDrug
After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
fospropofolDrug
After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
| Study group | Role | What they receive |
|---|---|---|
| fospropofol 6.5 mg/kg. | Active comparator | Patient randomized to receive fospropofol for awake intubation at 6.5 mg/kg. Receives: Drug: fospropofol |
| fospropofol 5 mg/kg. | Active comparator | Patient randomized to receive fospropofol for awake intubation at 5 mg/kg. Receives: Drug: fospropofol |
| fospropofol 3.5 mg/kg. | Active comparator | Patient randomized to receive fospropofol for awake intubation at 3 mg/kg. Receives: Drug: fospropofol |
| fospropofol 2 mg/kg. | Active comparator | Patient randomized to receive fospropofol for awake intubation at 2 mg/kg. Receives: Drug: fospropofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue intubation needed
Requiring rescue midazolam and or fentanyl to facilitate intubation
Measured: every 4 minutes during procedure, day 1
Hypotension
Development of hypotension ( defined as blood pressure drop of more than >30 % of base line) and/or hypoxemia ( SaO2 < 90% or a drop of >5% of baseline , whichever is lower)
Measured: every 2 minutes, during procedure, day 1
Secondary outcomes (7)
hypertension
Development of hypertension ( increase in blood pressure of > 30% of baseline), and/or tachycardia (120 beat/min or increase in heart rate of > 30% of base line, whichever is higher )
Measured: every 2 minutes, during procedure day 1
Total dose of midazolam and fentanyl used
Total dose of midazolam and fentanyl used
Measured: end of procedure, day 1
ease of intubation
anesthesiologists' assessment of ease of intubation on a visual analog scale (VAS) of 0-10, with 0 being very easy, and 10 being very difficult.
Measured: seconds, after intubation, day 1
Patient recall and satisfaction
Patient recall and satisfaction
Measured: end of procedure,day 1
Time to intubate
Time to intubation ( first fospropofol bolus to positive EtCO2 )
Measured: seconds, during procedure, day 1
Failed intubation
Failed intubation
Measured: seconds, day 1
unresponsiveness
Patient becoming un-responsive and /or requiring bag-mask Ventilation
Measured: seconds, during procedure, day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: sponsor has decided not to support this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Airway ClearanceStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Basem Abdelmalak, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289483
- Sponsor's protocol ID
- 10-808
- Status last verified
- Apr 2017
- First submitted
- 31 Jan 2011
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fospropofol for Sedation During Elective Awake Intubation
- ClinicalTrials.gov ID
- NCT01289483
- Acronym / sponsor ID
- 10-808
- Conditions
- Impaired Airway Clearance
- Keywords
- awake fiberoptic intubation (AFI), difficult airway, fospropofol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor has decided not to support this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Feb 2011 (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.
Patients scheduled for awake fiberoptic intubation (AFI) because of potential difficult airway will be consented prior to intubation ASA Physical Status classification and history of difficult intubation will be recorded at screening. The investigators will also record the results of airway examination including Mallampati classification, thyromental distance, mouth opening, neck circumference, neck range of motion, presence or absence of beard and overbite, history of neck radiation, and mandibular protrusion test Informed consent will be obtained prior to the procedure from those patients who meet the inclusion and exclusion criteria.
Standard hemodynamic monitoring will be used in all patients including EKG, blood pressure, heart rate, respiratory rate and oxygen saturation. Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale will be used to assess the level of alertness/sedation. Two consecutive MOAA/S scores of 4 will be considered as the desired effect of moderate sedation.
For AFI procedure, IV will be started and oxygen will be administered. 4 L of oxygen will be delivered through nasal canula until the completion of the AFI procedure. Patient head will be positioned in the sniffing position, Topical anesthesia would be achieved using the topical administration of 4 percent lidocaine using atomized and MaDgic nebulizer, and 2% xylocaine Jel applied to the surface of Williams airway in a total dose of lidocaine not exceeding 10 mg/kg. Patients will be randomized to one of the four fospropofol treatment arms: 2, 3.5, 5, or 6.5 mg/kg
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fospropofol 6.5 mg/kg. | Active comparator | Drug: fospropofolPatient randomized to receive fospropofol for awake intubation at 6.5 mg/kg. |
| fospropofol 5 mg/kg. | Active comparator | Drug: fospropofolPatient randomized to receive fospropofol for awake intubation at 5 mg/kg. |
| fospropofol 3.5 mg/kg. | Active comparator | Drug: fospropofolPatient randomized to receive fospropofol for awake intubation at 3 mg/kg. |
| fospropofol 2 mg/kg. | Active comparator | Drug: fospropofolPatient randomized to receive fospropofol for awake intubation at 2 mg/kg. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: between 18-64 years of age
- ASA physical status 1-3 ( Except patients with severe cardiac and/or pulmonary disease
- Weight 60-90 Kg
- Elective surgery requiring awake FOI
- Male or female, female patients should not be pregnant (documented by morning of surgery urine pregnancy test result as per routine hospital policy) or lactating
Key exclusion criteria (4 listed)
- Previous exposure to any experimental drug within 30 days prior to study drug administration
- Raised intracranial pressure
- Patients for whom propofol is contraindicated
- Allergy to midazolam and/or fentanyl
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 |
|---|---|---|
| fospropofolAfter the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min | Drug | fospropofol 6.5 mg/kg. |
| fospropofolAfter the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min | Drug | fospropofol 5 mg/kg. |
| fospropofolAfter the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min | Drug | fospropofol 3.5 mg/kg. |
| fospropofolAfter the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min | Drug | fospropofol 2 mg/kg. |
Primary outcome
Rescue intubation needed
Time frame: every 4 minutes during procedure, day 1
Requiring rescue midazolam and or fentanyl to facilitate intubation
Hypotension
Time frame: every 2 minutes, during procedure, day 1
Development of hypotension ( defined as blood pressure drop of more than >30 % of base line) and/or hypoxemia ( SaO2 < 90% or a drop of >5% of baseline , whichever is lower)
7 secondary outcomes
hypertension
Time frame: every 2 minutes, during procedure day 1
Total dose of midazolam and fentanyl used
Time frame: end of procedure, day 1
ease of intubation
Time frame: seconds, after intubation, day 1
Patient recall and satisfaction
Time frame: end of procedure,day 1
Time to intubate
Time frame: seconds, during procedure, day 1
Failed intubation
Time frame: seconds, day 1
unresponsiveness
Time frame: seconds, during procedure, day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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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.
Basem Abdelmalak, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fospropofol in people with Impaired Airway Clearance, run by The Cleveland Clinic 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Apr 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rescue intubation needed (time frame: every 4 minutes during procedure, day 1). 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 18 Apr 2017.