Morbid ObesityObese-FOBNCT03046797
Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution?
A study testing Fibroptic intubation through Boussignac valve opening and Classic Fibroptic intubation in people with Morbid Obesity, run by Mansoura University at 2 sites in Egypt.
Trial summary
In this study, fiberoptic intubation through Boussignac valve, while ventilation of morbidly obese patients is maintained through the ventilator, will be studied. Researchers suggest that the technique will allow more time for intubation trial rather than conventional techniques of intubation without ventilation. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Fibroptic intubation through Boussignac valve opening and Classic Fibroptic intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 5 Feb 2017to 30 Dec 2017
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Morbidly obese patients (BMI above 40kg/m2) scheduled for elective surgery, with age between 20 to 45 years
Who cannot join
- unstable ischemic heart disease, uncontrolled systemic hypertension, previous history of difficult intubation and patients with basal oxygen saturation less than 94%
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mansoura university
Al Mansurah, Dkahleya
Gastroenterology center
Al Mansurah, 35516
About this study
In this study, fiberoptic intubation through Boussignac valve, while ventilation of morbidly obese patients is maintained through the ventilator, will be studied. Researchers suggest that the technique will allow more time for intubation trial rather than conventional techniques of intubation without ventilation. the Primary outcome will be the decrease of desaturation events during intubation. Secondary variables will include; stress response to intubation, the incidence of hypercapnia, hemodynamic response to intubation, successful intubation, the time required to intubation and operator satisfaction.
Read the detailed description
All patients will be subjected to a thorough preoperative evaluation including clinical assessment, ECG, Echocardiography, pulmonary function tests and laboratory investigations (CBC, SGOT, SGPT, Albumin, Serum creatinine) and basal arterial blood gases. All patients will be pre-medicated with intravenous infusion of pantoprazole (40 mg) and metoclopramide (10 mg). After pre-oxygenation with 100% oxygen for 5 minutes, anesthesia will be induced using propofol (1-2 mg/kg) preceded by 60 mgs of lidocaine, and rocronium (0.12 mg/kg). Mask ventilation will be maintained while a Boussignac valve is attached between the Y-circuit and the face mask. After full relaxation is achieved (60 second after TOF response disappears), intubation attempt will commence.
Intubation technique:
Patients of both, patients will be put in HELP position to facilitate both ventilation and incubation
- In C group: mask ventilation will be terminated then FOB intubation will be done by experienced anesthist.
- In B group: Mask ventilation will be continued and FOB intubation will be performed from Boussignac valve opening.
Data collection:
Patient demographic data (Age, Weight, height, BMI, ASA status, coexisting diseases) will be collected. Hemodynamic parameters will be r5ecorded at the following points (Preoperative, basal, 1,2,3 minutes after starting intubation attempt).
Time to successful intubation will be documented in seconds (starting from passing of FOB through mouth opening till successful placement of the tube in the trachea). Also, time to glottis visualization and time to carina visualization will be recorded. Number of attempts will be also recorded where unsuccessful attempt will be defined as the need to withdraw FOB outside the patient's mouth (either due to failure to progress or need for ventilation). a desaturation event will be defined as SpO2 less than 94. Also, any procedure-related complication will be documented (hypertension, arrhythmia, spasm, bleeding) Statistical analysis G*power software version 3.1.9.2 was used for sample size calculation. We assumed that using Boussignac valve during FOB intubation can produce a 20% increase in the time to reach patients spo2 of 95% (180±20 sec in previous studies). It was found that 16 patients per was required to achieve a power of 90% with an alpha error of 0.05. additional 4 patients were added to compensate or dropouts making a total sample size of 40 patients.
Data will be collected and tabulated in excel sheet (Microsoft office, 2016). Statistical analysis will be performed using SPSS software version 20. Continuous data will be tested for normality of distribution and presented as mean±SD or median (interquartile range). Statistical differences between the studied groups will be assessed using appropriate statistical tests
- Conditions
- Morbid Obesity
- Being tested
- Fibroptic intubation through Boussignac valve opening, Classic Fibroptic intubation
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroptic intubation through Boussignac valve openingDevice
After patients being put in HELP position to facilitate both ventilation and intubation, mask ventilation will be continued and FOB intubation will be performed from Boussignac valve opening.
Classic Fibroptic intubationDevice
After patients being put in HELP position to facilitate both ventilation and incubation, mask ventilation will be terminated then FOB intubation will be done by an experienced anesthetist.
| Study group | Role | What they receive |
|---|---|---|
| B group | Experimental | Mask ventilation will be continued and fiberoptic intubation will be performed from Boussignac valve opening by an experienced anesthetist. Receives: Device: Fibroptic intubation through Boussignac valve opening |
| C group | Active comparator | mask ventilation will be terminated then fiberoptic intubation will be done by an experienced anesthetist. Receives: Device: Classic Fibroptic intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of desaturation events
desaturation (spo2 less than 94) during fibroptic intubation of morbidly obese patients
Measured: 3 minutes after the start of intubation attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start5 Feb 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046797
- Sponsor's protocol ID
- Obese-FOB
- Acronym
- Obese-FOB
- Status last verified
- Jan 2018
- First submitted
- 5 Feb 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution?
- ClinicalTrials.gov ID
- NCT03046797
- Acronym / sponsor ID
- Obese-FOB / Obese-FOB
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Feb 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 8 Feb 2017 (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.
In this study, fiberoptic intubation through Boussignac valve, while ventilation of morbidly obese patients is maintained through the ventilator, will be studied. Researchers suggest that the technique will allow more time for intubation trial rather than conventional techniques of intubation without ventilation. the Primary outcome will be the decrease of desaturation events during intubation. Secondary variables will include; stress response to intubation, the incidence of hypercapnia, hemodynamic response to intubation, successful intubation, the time required to intubation and operator satisfaction.
Detailed description
All patients will be subjected to a thorough preoperative evaluation including clinical assessment, ECG, Echocardiography, pulmonary function tests and laboratory investigations (CBC, SGOT, SGPT, Albumin, Serum creatinine) and basal arterial blood gases. All patients will be pre-medicated with intravenous infusion of pantoprazole (40 mg) and metoclopramide (10 mg). After pre-oxygenation with 100% oxygen for 5 minutes, anesthesia will be induced using propofol (1-2 mg/kg) preceded by 60 mgs of lidocaine, and rocronium (0.12 mg/kg). Mask ventilation will be maintained while a Boussignac valve is attached between the Y-circuit and the face mask. After full relaxation is achieved (60 second after TOF response disappears), intubation attempt will commence.
Intubation technique:
Patients of both, patients will be put in HELP position to facilitate both ventilation and incubation
- In C group: mask ventilation will be terminated then FOB intubation will be done by experienced anesthist.
- In B group: Mask ventilation will be continued and FOB intubation will be performed from Boussignac valve opening.
Data collection:
Patient demographic data (Age, Weight, height, BMI, ASA status, coexisting diseases) will be collected. Hemodynamic parameters will be r5ecorded at the following points (Preoperative, basal, 1,2,3 minutes after starting intubation attempt).
Time to successful intubation will be documented in seconds (starting from passing of FOB through mouth opening till successful placement of the tube in the trachea). Also, time to glottis visualization and time to carina visualization will be recorded. Number of attempts will be also recorded where unsuccessful attempt will be defined as the need to withdraw FOB outside the patient's mouth (either due to failure to progress or need for ventilation). a desaturation event will be defined as SpO2 less than 94. Also, any procedure-related complication will be documented (hypertension, arrhythmia, spasm, bleeding) Statistical analysis G*power software version 3.1.9.2 was used for sample size calculation. We assumed that using Boussignac valve during FOB intubation can produce a 20% increase in the time to reach patients spo2 of 95% (180±20 sec in previous studies). It was found that 16 patients per was required to achieve a power of 90% with an alpha error of 0.05. additional 4 patients were added to compensate or dropouts making a total sample size of 40 patients.
Data will be collected and tabulated in excel sheet (Microsoft office, 2016). Statistical analysis will be performed using SPSS software version 20. Continuous data will be tested for normality of distribution and presented as mean±SD or median (interquartile range). Statistical differences between the studied groups will be assessed using appropriate statistical tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B group | Experimental | Device: Fibroptic intubation through Boussignac valve openingMask ventilation will be continued and fiberoptic intubation will be performed from Boussignac valve opening by an experienced anesthetist. |
| C group | Active comparator | Device: Classic Fibroptic intubationmask ventilation will be terminated then fiberoptic intubation will be done by an experienced anesthetist. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Morbidly obese patients (BMI above 40kg/m2) scheduled for elective surgery, with age between 20 to 45 years
Key exclusion criteria (1 listed)
- unstable ischemic heart disease, uncontrolled systemic hypertension, previous history of difficult intubation and patients with basal oxygen saturation less than 94%
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 |
|---|---|---|
| Fibroptic intubation through Boussignac valve openingAfter patients being put in HELP position to facilitate both ventilation and intubation, mask ventilation will be continued and FOB intubation will be performed from Boussignac valve opening. | Device | B group |
| Classic Fibroptic intubationAfter patients being put in HELP position to facilitate both ventilation and incubation, mask ventilation will be terminated then FOB intubation will be done by an experienced anesthetist. | Device | C group |
Primary outcome
number of desaturation events
Time frame: 3 minutes after the start of intubation attempt
desaturation (spo2 less than 94) during fibroptic intubation of morbidly obese patients
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 8 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibroptic intubation through Boussignac valve opening and Classic Fibroptic intubation in people with Morbid Obesity, run by Mansoura University at 2 sites in Egypt.
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 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
number of desaturation events (time frame: 3 minutes after the start of intubation attempt). 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 8 Jan 2018.