Intubation;DifficultNCT03861949
Effectiveness of Preoxygenation With Positive Airway Pressure: a Comparison of the Supine and 25° Head up Position
A study testing 5 cmH2O CPAP and head-up position in people with Intubation;Difficult, run by B.P. Koirala Institute of Health Sciences.
Trial summary
Several techniques such as positive airway pressure and head-up tilt during preoxygenation have shown to prolong non-hypoxic apnea period compared to conventional technique. However, uniform recommendations have not yet been made. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- 5 cmH2O CPAP and head-up position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2014to 15 Jun 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult patients of ASA physical status I and II undergoing surgery under general anaesthesia
Who cannot join
- anticipated difficult mask ventilation/ intubation
- individuals with significant cardiorespiratory or cerebrovascular disease
- pregnant ladies
- patient with history of epilepsy
- body mass index >25 kg/m2
- hemoglobin <8 gm/dL
- patients who were non-ambulant for >24 h, having SpO2 < 97% while breathing in room air
- phobia to facemask.
About this study
Official title: Effectiveness of Preoxygenation With Positive Airway Pressure in Non-obese Healthy Patient: a Comparison of the Supine and 25° Head up Position
Several techniques such as positive airway pressure and head-up tilt during preoxygenation have shown to prolong non-hypoxic apnea period compared to conventional technique. However, uniform recommendations have not yet been made. Therefore, in the present study the investigators attempted to find out the effect of combination of 5 cmH2O CPAP and 25° head up position during preoxygenation.
Read the detailed description
In this study 60 non-obese healthy adult patients were divided into three groups; Group C receiving preoxygenation in conventional technique, Group S receiving preoxygenation with 5 cmH2O CPAP and Group H receiving preoxygenation in 25° head-up position with 5 cmH2O CPAP. After 3 min of preoxygenation, anesthesia was induced and trachea intubated. After confirming the tracheal intubation by direct visualization, all patients were left apneic in supine position with the tracheal tube exposed to atmosphere till the SpO2 dropped to 92%. The primary outcome compared between the groups was the non-hypoxic apnoeic period (time to fall SpO2 to 92%).
- Conditions
- Intubation;Difficult
- Being tested
- 5 cmH2O CPAP, head-up position
- Keywords
- apnea, CPAP, Preoxygenation
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 cmH2O CPAPOther
head-up positionOther
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | preoxygenation done with 100% oxygen in supine position |
| Positive-pressure | Experimental | preoxygenation done with 5 cmH2O CPAP (continuous positive airway pressure) in supine position with 100% oxygen Receives: Other: 5 cmH2O CPAP |
| Head-up | Experimental | preoxygenation done in 25 degree head-up position with 5 cmH2O CPAP with 100% oxygen Receives: Other: 5 cmH2O CPAP; Other: head-up position |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-hypoxic apnoeic period (time to fall SpO2 to 92%)
After 3 min of preoxygenation, anesthesia was induced and trachea intubated. After confirming the tracheal intubation by direct visualization, all patients were left apneic in supine position with the tracheal tube exposed to atmosphere till the SpO2 dropped to 92%.
Measured: 2 hours
Secondary outcomes (3)
Comparison of pH at different time points
Arterial blood gas analysis was done and the pH at the start of preoxygenation, after preoxygenation and at desaturation (SpO2= 92%) were compared.
Measured: 2 hours
Comparison of PaO2 at different time points
Arterial blood gas analysis was done and the PaO2 at the start of preoxygenation, after preoxygenation and at desaturation (SpO2= 92%) were compared.
Measured: 2 hours
Comparison of PaCO2 at different time points
Arterial blood gas analysis was done and the PaCO2 at the start of preoxygenation, after preoxygenation and at desaturation (SpO2= 92%) were compared.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start15 Jun 2014
- Primary completion15 Jun 2015
- Study completion15 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yogesh Dhakal, B.P. Koirala Institute of Health Sciences
- Investigators
- Balkrishna Bhattarai, Professor, Principal investigator, B.P. Koirala Institute of Health SciencesSindhu Khatiwada, Professor, Principal investigator, B.P. Koirala Institute of Health SciencesAsish Subedi, Dr, Principal investigator, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861949
- Sponsor's protocol ID
- IERB/205/014
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Preoxygenation With Positive Airway Pressure in Non-obese Healthy Patient: a Comparison of the Supine and 25° Head up Position
- ClinicalTrials.gov ID
- NCT03861949
- Acronym / sponsor ID
- IERB/205/014
- Conditions
- Intubation;Difficult
- Keywords
- apnea, CPAP, Preoxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 15 Jun 2014 (actual)
- Primary completion
- 15 Jun 2015 (actual)
- Study completion
- 15 Jun 2015 (actual)
- First posted
- 5 Mar 2019 (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.
Several techniques such as positive airway pressure and head-up tilt during preoxygenation have shown to prolong non-hypoxic apnea period compared to conventional technique. However, uniform recommendations have not yet been made. Therefore, in the present study the investigators attempted to find out the effect of combination of 5 cmH2O CPAP and 25° head up position during preoxygenation.
Detailed description
In this study 60 non-obese healthy adult patients were divided into three groups; Group C receiving preoxygenation in conventional technique, Group S receiving preoxygenation with 5 cmH2O CPAP and Group H receiving preoxygenation in 25° head-up position with 5 cmH2O CPAP. After 3 min of preoxygenation, anesthesia was induced and trachea intubated. After confirming the tracheal intubation by direct visualization, all patients were left apneic in supine position with the tracheal tube exposed to atmosphere till the SpO2 dropped to 92%. The primary outcome compared between the groups was the non-hypoxic apnoeic period (time to fall SpO2 to 92%).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –preoxygenation done with 100% oxygen in supine position |
| Positive-pressure | Experimental | Other: 5 cmH2O CPAPpreoxygenation done with 5 cmH2O CPAP (continuous positive airway pressure) in supine position with 100% oxygen |
| Head-up | Experimental | Other: 5 cmH2O CPAP, Other: head-up positionpreoxygenation done in 25 degree head-up position with 5 cmH2O CPAP with 100% oxygen |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult patients of ASA physical status I and II undergoing surgery under general anaesthesia
Key exclusion criteria (8 listed)
- anticipated difficult mask ventilation/ intubation
- individuals with significant cardiorespiratory or cerebrovascular disease
- pregnant ladies
- patient with history of epilepsy
- body mass index >25 kg/m2
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 |
|---|---|---|
| 5 cmH2O CPAP | Other | Head-up, Positive-pressure |
| head-up position | Other | Head-up |
Primary outcome
non-hypoxic apnoeic period (time to fall SpO2 to 92%)
Time frame: 2 hours
After 3 min of preoxygenation, anesthesia was induced and trachea intubated. After confirming the tracheal intubation by direct visualization, all patients were left apneic in supine position with the tracheal tube exposed to atmosphere till the SpO2 dropped to 92%.
3 secondary outcomes
Comparison of pH at different time points
Time frame: 2 hours
Comparison of PaO2 at different time points
Time frame: 2 hours
Comparison of PaCO2 at different time points
Time frame: 2 hours
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 6 Mar 2019.
- 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.
Balkrishna Bhattarai, Professor principal investigator
B.P. Koirala Institute of Health Sciences
Sindhu Khatiwada, Professor principal investigator
B.P. Koirala Institute of Health Sciences
Asish Subedi, Dr principal investigator
B.P. Koirala Institute of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing 5 cmH2O CPAP and head-up position in people with Intubation;Difficult, run by B.P. Koirala Institute of Health Sciences.
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 8 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
non-hypoxic apnoeic period (time to fall SpO2 to 92%) (time frame: 2 hours). 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 6 Mar 2019.