Desaturation of BloodHFNCNCT02968706
HFNC Versus Conventional Nasal Cannula in Oxygen Performance in Patients Receiving Colonoscopy Under IV Sedation
A study testing High Flow Nasal Cannula, Conventional Nasal Cannula and Patient satisfaction questionnaire in people with Desaturation of Blood, run by Aventura Hospital and Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate if high flow nasal cannula (HFNC), as compared to conventional nasal cannula, improves oxygenation and prevents desaturation events in obese patients undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Desaturation of Blood
- What is being tested?
- High Flow Nasal Cannula, Conventional Nasal Cannula and Patient satisfaction questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 30.
- Age ≥ 18 years.
- ASA classification II and III.
- Scheduled for colonoscopy.
- Able to provide written informed consent.
Who cannot join
- Allergic to propofol and any of its contents.
- Baseline SpO2 less than 93%.
- Patients who require intubation for airway protection based on anesthesiologist discretion.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Aventura Hospital and Medical Center
Aventura, Florida, 33180
Hilda Mahmoudi, MD, MPH, 305-682-7261, Hilda.mahmoudi@hcahealthcare.com
Jestin Pudussery Kattalan, MD, Jestin.PudusseryKattalan@hcahealthcare.com
About this study
Official title: High Flow Nasal Cannula Versus Conventional Nasal Cannula in Oxygen Performance in Patients Receiving Colonoscopy Under Intravenous Sedation
The purpose of this study is to investigate if high flow nasal cannula (HFNC), as compared to conventional nasal cannula, improves oxygenation and prevents desaturation events in obese patients undergoing colonoscopy.
Read the detailed description
Intravenous sedation during colonoscopy has become the standard practice in United States given its higher patient satisfaction and procedural quality. The most common used short acting sedative agent is propofol. Although possessing safe and rapidly reversed pharmacokinetic properties, propofol intravenous infusion can lead to respiratory depression and hypoxemia. In one prospective study, hypoxemia events, defined by oxygen saturation less than 90 percent was found in 20 percent of patients receiving colonoscopy using propofol sedation. The mechanism of hypoxemia is mainly hypoventilation, airway collapse, and carbon dioxide (CO2) retention. When it comes to gastrointestinal procedures, using oxygen devices for augmenting ventilation is usually avoided, ex: positive pressure ventilation, since it can lead to bowel distention and affect quality of procedures. Therefore most hospitals in United States still use nasal cannula of oxygen therapy during gastrointestinal procedures, and there is lack of available options of oxygen therapy which can improve hypoventilation and prevent hypoxemia.
High flow nasal cannula (HFNC) is a new generation of oxygen therapy. It provides constant high flow oxygen delivery with heated and humidified air. Moreover, it has been studied that high velocity of airflow can create the effect of "positive end expiratory pressure" thus assist ventilation and work of breathing. Compared to conventional nasal cannula and face mask, HFNC has demonstrated superior performance in oxygenation, work of breathing and patient comfort in many studies. Since its invention, HFNC has been studied in post-cardiac surgery, post-extubation, bronchoscopy and dental procedures and all of them show equal to better oxygen performance in comparison of nasal cannula.
While capnographic monitoring has been studied to prevent hypoxemia during sedation, no studies have been done to evaluate the clinical utility of new generation oxygen therapy. Obesity is associated with increased frequency of sedation related complications especially hypoxemia during propofol mediated sedation for advanced endoscopic procedures. The Investigators hypothesized that HFNC may improve oxygen performance compared to conventional nasal cannula for obese patients receiving colonoscopy under intravenous sedation.
- Conditions
- Desaturation of Blood
- Being tested
- High Flow Nasal Cannula, Conventional Nasal Cannula, Patient satisfaction questionnaire
- Keywords
- High Flow Nasal Cannula, Colonoscopy, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CannulaDevice
Also called High flow oxygen delivering device (OPTIFLO)
Heated humidified high flow oxygen of 50 L/min at FiO2 of 40%
Conventional Nasal CannulaDevice
Supplemental oxygen of 2-5 L/min
Patient satisfaction questionnaireOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| High flow cannula arm | Experimental | Patients in the experimental arm (the high flow nasal cannula group) will receive heated humidified high flow oxygen of 50L/min at FiO2 of 40% throughout the colonoscopy. A patient satisfaction survey will be administered after procedure. Receives: Device: High Flow Nasal Cannula; Other: Patient satisfaction questionnaire |
| Conventional cannula arm | Active comparator | Participants in control arm (the conventional nasal cannula group) will receive an oxygen flow of 2-5 L /min. A patient satisfaction survey will be administered after procedure. Receives: Device: Conventional Nasal Cannula; Other: Patient satisfaction questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of desaturation events during procedures (desaturation events are defined by either SpO2 drops more than 5% compared to baseline SpO2 OR SpO2<90% at any time of procedures)
Measured: Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)
Secondary outcomes (4)
Incidence rate of carbon dioxide retention (end tidal CO2 more than 50 mmHg at any time of procedure)
Measured: Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)
Patients satisfaction level (patient comfort and mouth dryness assessed by a questionnaire with 4-scale questions)
Measured: One time point (15 minutes after the patient recovered from anesthesia sedation)
Respiratory rates before and after colonoscopy procedure, and highest respiratory rate during colonoscopy procedure.
Measured: Three time points (Before, through out, and within 5 minutes after the colonoscopy procedure)
Incidence rate of hypoxia rescue intervention events (e.g. jaw lift, anterior mandibular shifting, head elevation )
Measured: Through out the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desaturation of BloodStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aventura Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilda Mahmoudi, MD, MPH, Principal investigator, Aventura Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968706
- Sponsor's protocol ID
- 2016-516
- Acronym
- HFNC
- Status last verified
- Feb 2017
- First submitted
- 8 Nov 2016
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Versus Conventional Nasal Cannula in Oxygen Performance in Patients Receiving Colonoscopy Under Intravenous Sedation
- ClinicalTrials.gov ID
- NCT02968706
- Acronym / sponsor ID
- HFNC / 2016-516
- Conditions
- Desaturation of Blood
- Keywords
- High Flow Nasal Cannula, Colonoscopy, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aventura Hospital and Medical CenterUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 21 Nov 2016 (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.
The purpose of this study is to investigate if high flow nasal cannula (HFNC), as compared to conventional nasal cannula, improves oxygenation and prevents desaturation events in obese patients undergoing colonoscopy.
Detailed description
Intravenous sedation during colonoscopy has become the standard practice in United States given its higher patient satisfaction and procedural quality. The most common used short acting sedative agent is propofol. Although possessing safe and rapidly reversed pharmacokinetic properties, propofol intravenous infusion can lead to respiratory depression and hypoxemia. In one prospective study, hypoxemia events, defined by oxygen saturation less than 90 percent was found in 20 percent of patients receiving colonoscopy using propofol sedation. The mechanism of hypoxemia is mainly hypoventilation, airway collapse, and carbon dioxide (CO2) retention. When it comes to gastrointestinal procedures, using oxygen devices for augmenting ventilation is usually avoided, ex: positive pressure ventilation, since it can lead to bowel distention and affect quality of procedures. Therefore most hospitals in United States still use nasal cannula of oxygen therapy during gastrointestinal procedures, and there is lack of available options of oxygen therapy which can improve hypoventilation and prevent hypoxemia.
High flow nasal cannula (HFNC) is a new generation of oxygen therapy. It provides constant high flow oxygen delivery with heated and humidified air. Moreover, it has been studied that high velocity of airflow can create the effect of "positive end expiratory pressure" thus assist ventilation and work of breathing. Compared to conventional nasal cannula and face mask, HFNC has demonstrated superior performance in oxygenation, work of breathing and patient comfort in many studies. Since its invention, HFNC has been studied in post-cardiac surgery, post-extubation, bronchoscopy and dental procedures and all of them show equal to better oxygen performance in comparison of nasal cannula.
While capnographic monitoring has been studied to prevent hypoxemia during sedation, no studies have been done to evaluate the clinical utility of new generation oxygen therapy. Obesity is associated with increased frequency of sedation related complications especially hypoxemia during propofol mediated sedation for advanced endoscopic procedures. The Investigators hypothesized that HFNC may improve oxygen performance compared to conventional nasal cannula for obese patients receiving colonoscopy under intravenous sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow cannula arm | Experimental | Device: High Flow Nasal Cannula, Other: Patient satisfaction questionnairePatients in the experimental arm (the high flow nasal cannula group) will receive heated humidified high flow oxygen of 50L/min at FiO2 of 40% throughout the colonoscopy. A patient satisfaction survey will be administered after procedure. |
| Conventional cannula arm | Active comparator | Device: Conventional Nasal Cannula, Other: Patient satisfaction questionnaireParticipants in control arm (the conventional nasal cannula group) will receive an oxygen flow of 2-5 L /min. A patient satisfaction survey will be administered after procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI ≥ 30.
- Age ≥ 18 years.
- ASA classification II and III.
- Scheduled for colonoscopy.
- Able to provide written informed consent.
Key exclusion criteria (3 listed)
- Allergic to propofol and any of its contents.
- Baseline SpO2 less than 93%.
- Patients who require intubation for airway protection based on anesthesiologist discretion.
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 |
|---|---|---|
| High Flow Nasal CannulaAlso: High flow oxygen delivering device (OPTIFLO)Heated humidified high flow oxygen of 50 L/min at FiO2 of 40% | Device | High flow cannula arm |
| Conventional Nasal CannulaSupplemental oxygen of 2-5 L/min | Device | Conventional cannula arm |
| Patient satisfaction questionnaireQuestionnaire | Other | Conventional cannula arm, High flow cannula arm |
Primary outcome
Incidence rate of desaturation events during procedures (desaturation events are defined by either SpO2 drops more than 5% compared to baseline SpO2 OR SpO2<90% at any time of procedures)
Time frame: Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)
4 secondary outcomes
Incidence rate of carbon dioxide retention (end tidal CO2 more than 50 mmHg at any time of procedure)
Time frame: Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)
Patients satisfaction level (patient comfort and mouth dryness assessed by a questionnaire with 4-scale questions)
Time frame: One time point (15 minutes after the patient recovered from anesthesia sedation)
Respiratory rates before and after colonoscopy procedure, and highest respiratory rate during colonoscopy procedure.
Time frame: Three time points (Before, through out, and within 5 minutes after the colonoscopy procedure)
Incidence rate of hypoxia rescue intervention events (e.g. jaw lift, anterior mandibular shifting, head elevation )
Time frame: Through out the colonoscopy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 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.
Hilda Mahmoudi, MD, MPH principal investigator
Aventura Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula, Conventional Nasal Cannula and Patient satisfaction questionnaire in people with Desaturation of Blood, run by Aventura Hospital and Medical Center 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 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilda Mahmoudi, MD, MPH ((305) 682 7261, Hilda.Mahmoudi@hcahealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of desaturation events during procedures (desaturation events are defined by either SpO2 drops more than 5% compared to baseline SpO2 OR SpO2<90% at any time of procedures) (time frame: Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)). 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 20 Feb 2017.