HypoxiaNCT06482879
Comparison of Hypoxia Between HFNC and SNC in Patient Undergoing UGI Endoscopic Procedures in Deep Sedation
An observational study of Hypoxia, run by National Academy of Medical Sciences, Nepal at 1 site in Nepal.
Trial summary
Hypoxia frequently occurs as a complication during upper gastrointestinal endoscopic procedures performed under deep sedation. Traditional oxygen delivery methods, such as the simple nasal cannula, are commonly used to prevent hypoxia in these cases. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Hypoxia
- What is being tested?
- Oxygen delivery
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jul 2023to 20 Feb 2024
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing complex UGI endoscopic procedure in deep sedation under propofol infusion in tertiary care hospital of Nepal.
Inclusion Criteria: Patient aged more than 16 years ASA-PS grading I-IV, Both gender -
Exclusion Criteria: Patient not willing to enrolled, Pre-operative SPO2 < 92%, Pre-operative MAP < 60 mm Hg, Emergency procedure
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Hypoxia Between High Flow Nasal Canula and Simple Nasal Canula in Patient Undergoing Upper Gastrointestinal Endoscopic Procedures in Deep Sedation
Hypoxia frequently occurs as a complication during upper gastrointestinal endoscopic procedures performed under deep sedation. Traditional oxygen delivery methods, such as the simple nasal cannula, are commonly used to prevent hypoxia in these cases. The high-flow nasal cannula, capable of delivering FiO2 levels of up to 1 and flow rates of up to 70 l/min, offers additional benefits, including positive end-expiratory pressure and reduced dead space. We hypothesized is that the use of high-flow nasal cannula can decrease the incidence of hypoxia in comparison to simple nasal cannula in patients undergoing upper gastrointestinal endoscopic procedures under deep sedation.
This was prospective, comparative observational study conducted in a tertiary care center of Nepal with the primary objective to compare the rates of hypoxia (SpO2 < 92%) and secondary objectives were to compare interruption of procedure due to hypoxia, minimum hypoxia level and episodes of hypoxia between high flow nasal canula (flow rate of 30l/min with FiO2 of 0.5) and simple nasal canula (flow rate of 6l/min) in patients undergoing upper gastrointestinal endoscopic procedures in semi-prone position in deep sedation using propofol infusion.
The study comprised 125 participants, 58 in simple nasal canula and 67 in high flow nasal cannula group. The incidence of hypoxia in simple nasal cannula and high flow nasal cannula groups, with rates of 37.3% (22/58) and 16.4% (11/67), respectively. The relative risk (RR) of hypoxia was 0.43 (95% CI: 0.23-0.81), with a p-value of 0.009. Procedural interruptions due to hypoxia occurred in 8.6% (5/58) of participants in the simple nasal cannula group and 4.47% (3/67) in the high flow nasal cannula group, with RR of 0.17 (95% CI: 0.02-1.41) and a p-value 0.1. Furthermore, the occurrence of multiple episodes of hypoxia was higher in the simple nasal cannula group compared to the high flow nasal cannula group (5 vs. 0), with a p-value < 0.001.The use of high flow nasal cannula reduces the occurrence of hypoxia in patients undergoing upper gastrointestinal endoscopic procedures with deep sedation compared to simple nasal cannula.
Read the detailed description
This study was prospective, comparative, open-label and observational study conducted on tertiary hospital of Nepal between July 2023-April 2024.A written informed consent was taken from all the patients before enrolling to study. Patient aged more than 16 years, ASA-PS grading I-IV, both the gender, both elective procedures undergoing complex UGI endoscopic procedure in deep sedation under propofol infusion were included. Patient not willing to enrolled, pre-operative SPO2 < 92% and pre-operative MAP < 60 mm Hg were excluded from study. Sixty-two patients were enrolled in each group so total sample size was 124 using following sample size formula. .
After arriving in the procedure room, standard monitoring, including pulse oximetry, non-invasive blood pressure monitoring, and electrocardiography were attached. An anesthesiologist assigned made the decision on which oxygenation device to use for the patient. In SNC group, an oxygen flow rate of 6 l/min where in HFNC group at the beginning of procedure flow was set 10 l/min once patient was induced flow rate increased to 30 l/min with FiO2 of 0.5. The patients were positioned either laterally or semiprone. Prior to the start of the procedure, the patient was given an injection of fentanyl 1mcg/kg. An initial dose of propofol was administered at a rate of 1-1.5 mg/kg by slow titrating manner. The sedation level, ventilatory pattern,rate and depth were clinically monitored throughout the procedure.The propofol infusion was kept between 25-150 mcg/kg/min, aiming for preventing facial grimace, agitation, or gag reflex, while still allowing the patient to respond to painful stimuli. In case of any sings of agitation noticed, the anaesthesiologist added the additional dose of propofol or increase the propofol infusion rate or both, as in our usual practice.
In SNC group, if SpO2 decreased below 92%, flow rate increased to 8 l/min whereas in HFNC group FiO2 increased to 1 and flow rate increased to 50 l/min. If desaturation continued despite of above mentioned measure in both groups, anesthesiologist increased the FiO2, flow or both. Bag mask ventilation and tracheal intubation was done if needed. Other events; bradycardia needing atropine, hypotension needing vasopressor, persistent hypoxia needing bag and mask, endotracheal intubation was recorded.
Hypoxia is defined as a decrease in oxygen saturation < 92%. Severe hypoxia is defined as a decrease in oxygen saturation < 80%. Primary outcome was the compare the rate of hypoxia and secondary outcome was to compare the rate of interruption of procedure due to hypoxia and episodes of hypoxia during the procedure between the two groups.
- Conditions
- Hypoxia
- Being tested
- Oxygen delivery
- Keywords
- hypoxia, oxygen delivery device
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen deliveryDevice
Oxygen is delivered with high flow nasal canula or simple nasal canula to prevent hypoxia during procedures under deep sedation.
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal canula | Patient undergoing upper GI endoscopic procedure under deep sedation will receive high flow nasal canula. Receives: Device: Oxygen delivery | |
| Simple nasal canula | Patient undergoing upper GI endoscopic procedure under deep sedation will receive simple nasal canula. Receives: Device: Oxygen delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of incidence of hypoxia between high flow nasal canula and Simple nasal canula
Measured: During the procedure
Secondary outcomes (2)
Comparison of frequency of hypoxia between high flow nasal canula and Simple nasal canula
Measured: During the procedure
Comparison of interruption of procedure between high flow nasal canula and Simple nasal canula
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jul 2023
- Primary completion15 Jan 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Academy of Medical Sciences, Nepal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anuj Jung Karki, National Academy of Medical Sciences, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482879
- Sponsor's protocol ID
- NamsAnuj
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hypoxia Between High Flow Nasal Canula and Simple Nasal Canula in Patient Undergoing Upper Gastrointestinal Endoscopic Procedures in Deep Sedation
- ClinicalTrials.gov ID
- NCT06482879
- Acronym / sponsor ID
- NamsAnuj
- Conditions
- Hypoxia
- Keywords
- hypoxia, oxygen delivery device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- National Academy of Medical Sciences, NepalOther government
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 1 Jul 2024 (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.
Hypoxia frequently occurs as a complication during upper gastrointestinal endoscopic procedures performed under deep sedation. Traditional oxygen delivery methods, such as the simple nasal cannula, are commonly used to prevent hypoxia in these cases. The high-flow nasal cannula, capable of delivering FiO2 levels of up to 1 and flow rates of up to 70 l/min, offers additional benefits, including positive end-expiratory pressure and reduced dead space. We hypothesized is that the use of high-flow nasal cannula can decrease the incidence of hypoxia in comparison to simple nasal cannula in patients undergoing upper gastrointestinal endoscopic procedures under deep sedation.
This was prospective, comparative observational study conducted in a tertiary care center of Nepal with the primary objective to compare the rates of hypoxia (SpO2 < 92%) and secondary objectives were to compare interruption of procedure due to hypoxia, minimum hypoxia level and episodes of hypoxia between high flow nasal canula (flow rate of 30l/min with FiO2 of 0.5) and simple nasal canula (flow rate of 6l/min) in patients undergoing upper gastrointestinal endoscopic procedures in semi-prone position in deep sedation using propofol infusion.
The study comprised 125 participants, 58 in simple nasal canula and 67 in high flow nasal cannula group. The incidence of hypoxia in simple nasal cannula and high flow nasal cannula groups, with rates of 37.3% (22/58) and 16.4% (11/67), respectively. The relative risk (RR) of hypoxia was 0.43 (95% CI: 0.23-0.81), with a p-value of 0.009. Procedural interruptions due to hypoxia occurred in 8.6% (5/58) of participants in the simple nasal cannula group and 4.47% (3/67) in the high flow nasal cannula group, with RR of 0.17 (95% CI: 0.02-1.41) and a p-value 0.1. Furthermore, the occurrence of multiple episodes of hypoxia was higher in the simple nasal cannula group compared to the high flow nasal cannula group (5 vs. 0), with a p-value < 0.001.The use of high flow nasal cannula reduces the occurrence of hypoxia in patients undergoing upper gastrointestinal endoscopic procedures with deep sedation compared to simple nasal cannula.
Detailed description
This study was prospective, comparative, open-label and observational study conducted on tertiary hospital of Nepal between July 2023-April 2024.A written informed consent was taken from all the patients before enrolling to study. Patient aged more than 16 years, ASA-PS grading I-IV, both the gender, both elective procedures undergoing complex UGI endoscopic procedure in deep sedation under propofol infusion were included. Patient not willing to enrolled, pre-operative SPO2 < 92% and pre-operative MAP < 60 mm Hg were excluded from study. Sixty-two patients were enrolled in each group so total sample size was 124 using following sample size formula. .
After arriving in the procedure room, standard monitoring, including pulse oximetry, non-invasive blood pressure monitoring, and electrocardiography were attached. An anesthesiologist assigned made the decision on which oxygenation device to use for the patient. In SNC group, an oxygen flow rate of 6 l/min where in HFNC group at the beginning of procedure flow was set 10 l/min once patient was induced flow rate increased to 30 l/min with FiO2 of 0.5. The patients were positioned either laterally or semiprone. Prior to the start of the procedure, the patient was given an injection of fentanyl 1mcg/kg. An initial dose of propofol was administered at a rate of 1-1.5 mg/kg by slow titrating manner. The sedation level, ventilatory pattern,rate and depth were clinically monitored throughout the procedure.The propofol infusion was kept between 25-150 mcg/kg/min, aiming for preventing facial grimace, agitation, or gag reflex, while still allowing the patient to respond to painful stimuli. In case of any sings of agitation noticed, the anaesthesiologist added the additional dose of propofol or increase the propofol infusion rate or both, as in our usual practice.
In SNC group, if SpO2 decreased below 92%, flow rate increased to 8 l/min whereas in HFNC group FiO2 increased to 1 and flow rate increased to 50 l/min. If desaturation continued despite of above mentioned measure in both groups, anesthesiologist increased the FiO2, flow or both. Bag mask ventilation and tracheal intubation was done if needed. Other events; bradycardia needing atropine, hypotension needing vasopressor, persistent hypoxia needing bag and mask, endotracheal intubation was recorded.
Hypoxia is defined as a decrease in oxygen saturation < 92%. Severe hypoxia is defined as a decrease in oxygen saturation < 80%. Primary outcome was the compare the rate of hypoxia and secondary outcome was to compare the rate of interruption of procedure due to hypoxia and episodes of hypoxia during the procedure between the two groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal canula | – | Device: Oxygen deliveryPatient undergoing upper GI endoscopic procedure under deep sedation will receive high flow nasal canula. |
| Simple nasal canula | – | Device: Oxygen deliveryPatient undergoing upper GI endoscopic procedure under deep sedation will receive simple nasal canula. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing complex UGI endoscopic procedure in deep sedation under propofol infusion in tertiary care hospital of Nepal.
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 |
|---|---|---|
| Oxygen deliveryOxygen is delivered with high flow nasal canula or simple nasal canula to prevent hypoxia during procedures under deep sedation. | Device | High flow nasal canula, Simple nasal canula |
Primary outcome
Comparison of incidence of hypoxia between high flow nasal canula and Simple nasal canula
Time frame: During the procedure
2 secondary outcomes
Comparison of frequency of hypoxia between high flow nasal canula and Simple nasal canula
Time frame: During the procedure
Comparison of interruption of procedure between high flow nasal canula and Simple nasal canula
Time frame: During the procedure
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 1 Jul 2024.
- 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.
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 Hypoxia, run by National Academy of Medical Sciences, Nepal at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Jul 2024. 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 Nepal. 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?
Comparison of incidence of hypoxia between high flow nasal canula and Simple nasal canula (time frame: During the procedure). 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 1 Jul 2024.