Ventilatory DepressionNCT03374644
Correlation of ETCO2 to PaCO2 Measured by Sentri Nasal Cannula
A study testing SentriTM ETCO2 adult nasal cannula in people with Ventilatory Depression, run by University of Malaya.
Trial summary
Sampling end tidal gas via nasal prong has been shown to be a noninvasive and reliable method of monitoring end-tidal CO2 in spontaneously breathing patients. It is used to assess the adequacy of ventilation and enhance patient safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilatory Depression
- What is being tested?
- SentriTM ETCO2 adult nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2018to 30 Aug 2018
- 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
- Patients who are classified as ASA (American Society of Anesthesiologist) physical status 1 to 3 with age more than 18 years' old, and are scheduled for elective eye surgery
Who cannot join
- Patients who are less than 18 years old, have chronic lung disease, nasal obstruction, nasal congestion or craniofacial abnormalities
About this study
Official title: Correlation of End Tidal Carbon Dioxide to Arterial Partial Pressure Carbon Dioxide Measured by Sentri Nasal Cannula. A Study in Spontaneously Breathing Non Intubated Patients Undergoing Cataract Surgery With Local Anaesthesia
Sampling end tidal gas via nasal prong has been shown to be a noninvasive and reliable method of monitoring end-tidal CO2 in spontaneously breathing patients. It is used to assess the adequacy of ventilation and enhance patient safety. When using a nasal cannula to sample expired gases by a patient, air from the room may dilute the sample and affect the accuracy of ETCO2. It is necessary to have accurate values of ETCO2 during intravenous sedation to detect respiratory depression including apnea. Therefore, the aim of our study is to assess the correlation of end tidal carbon dioxide to arterial partial pressure of carbon dioxide by using Sentri nasal cannula among sedated and non-sedated patient undergoing cataract surgery under local anaesthesia. Patients who are classified as ASA physical status 1 to 3 with age more than 18 years' old, and are scheduled for elective eye surgery in which arterial blood pressure monitoring is appropriate will be eligible. This study will be conducted at University Malaya Medical Centre.
Read the detailed description
After due approval from ethical review board and written consent, 40 patients who is scheduled for an elective eye procedure in which direct arterial blood pressure monitoring is appropriate will be recruited into this study. End tidal carbon dioxide will be sampled via SentriTM ETCO2 adult nasal cannula (Intersurgical ® code 1144002) during preoperative and intraoperative period. ETCO2 is measured by infrared spectroscopy (Datex-Ohmeda GE Healthcare S5, Compact monitor, Switzerland) with a side stream aspirator which has a flow rate of 150mL/min.
Standard monitoring with continuous electrography (ECG), non-invasive blood pressure(NIBP) monitoring and pulse oximetry will be used for all patients. A baseline blood pressure, heart rate, respiratory rate, oxygen saturation (SaO2) and ETCO2 will be recorded. During preoperative period, a 20-gauge, radial artery catheter was inserted under aseptic technique. It is used to obtain arterial blood gas measurement of partial pressure oxygen and carbon dioxide (PaO2, PaCO2) Blood gas will be analyzed by using ABL 800 flex blood gas analyzer (Radiometer Medical ApS, Denmark) with calibrations recommended by the manufacturer. No sedation will be given during preoperative period.
Following the placement of indwelling radial artery catheter, Sentri nasal cannula will be placed into the nostril of the patients Subjects will be asked to breath normally for a period of five minutes . Nasal breathing will be confirmed by presence of an acceptable CO2 tracing.Blood is drawn from indwelling arterial catheter for blood gas determination 5 minutes after the modified nasal cannulae is in place. At the same time as the arterial blood gas sample is taken, an ETCO2 sample is also obtained. A baseline (without oxygen flow) ETCO2, PaO2, SPO2, respiratory rate and PaCO2 will be recorded. The respiratory rate will be determined by counting the respiration for 15 seconds and multiplying by four. Subjects will not be asked to keep their mouth close when using the nasal cannula as it might alter the variability inherent in patients who mouth breathe during conscious sedation. After a baseline ETCO2 is established, oxygen will be administered at 2,4, and 6 liters per minute for a period of five minutes. At each level of oxygen administration, an average ETC02 reading will be recorded after achieving stable recordings. Simultaneously, PaO2 and PaCO2 will be obtained by drawing arterial blood from arterial indwelling catheter. Heart rate, respiratory rate, blood pressure will also be routinely recorded.
Sedation will be given to the patients intraoperatively. Riker Sedation-Agitation Scale (SAS) will be used to assess the level of sedation during intraoperative period. Titrated dose of midazolam will be given to the patient with the target of SAS score of 3 (difficult to arouse but awakens to verbal stimuli or gentle shaking, follow simple commands but drifts off again). During intraoperative period, oxygen will be administered at 2 and 4 liters per minutes for a period of five minutes. ETCO2, PaCO2 and PaO2 level will be recorded during each level of oxygen administration.
- Conditions
- Ventilatory Depression
- Being tested
- SentriTM ETCO2 adult nasal cannula
- Keywords
- Correlation, ETCO2, PaCO2, nasal cannula, Sentri Nasal Cannula
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SentriTM ETCO2 adult nasal cannulaDevice
Sentri nasal cannula is the device which designed to sample exhaled ETCO2 in non-intubated patients during the administration of supplementary oxygen. By delivering oxygen through one prong and sampling exhaled gas from the other prong, the nasal cannula can provide end tidal values comparable to those achieved with intubated patients. It is fitted to the patients as same manner as conventional nasal cannula. Furthermore, it consists of curved prong to improve the anatomical fit.
| Study group | Role | What they receive |
|---|---|---|
| ETCO2 monitoring with nasal cannula | Experimental | SentriTM ETCO2 adult nasal cannula (Intersurgical ® code 1144002) will be placed into patient's nostril following radial artery catheter insertion. A baseline (without oxygen flow) ETCO2, PaO2, SPO2, RR and PaCO2 will be recorded. Oxygen will then be administered at 2,4, and 6 liters per minute for a period of five minutes.ETCO2, PaCO2 and PaO2 will be recorded for each level of oxygen administration.Sedation will be given during intra-operative period with the target of Observer Assessment of alertness/sedation scale (OAA/S) score of 3. During intraoperative period, oxygen will be administered at 2 and 4 liters per minute for a period of five minutes. ETCO2, PaCO2 and PaO2 level will be recorded during each level of oxygen administration. Receives: Device: SentriTM ETCO2 adult nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of end tidal carbon dioxide as a measure of arterial carbon dioxide levels by using Sentri cannula
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start15 Jan 2018 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilatory DepressionStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Lee Jia Wen, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374644
- Sponsor's protocol ID
- 2017925-5591
- Status last verified
- Dec 2017
- First submitted
- 15 Nov 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- 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 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of End Tidal Carbon Dioxide to Arterial Partial Pressure Carbon Dioxide Measured by Sentri Nasal Cannula. A Study in Spontaneously Breathing Non Intubated Patients Undergoing Cataract Surgery With Local Anaesthesia
- ClinicalTrials.gov ID
- NCT03374644
- Acronym / sponsor ID
- 2017925-5591
- Conditions
- Ventilatory Depression
- Keywords
- Correlation, ETCO2, PaCO2, nasal cannula, Sentri Nasal Cannula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 15 Dec 2017 (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.
Sampling end tidal gas via nasal prong has been shown to be a noninvasive and reliable method of monitoring end-tidal CO2 in spontaneously breathing patients. It is used to assess the adequacy of ventilation and enhance patient safety. When using a nasal cannula to sample expired gases by a patient, air from the room may dilute the sample and affect the accuracy of ETCO2. It is necessary to have accurate values of ETCO2 during intravenous sedation to detect respiratory depression including apnea. Therefore, the aim of our study is to assess the correlation of end tidal carbon dioxide to arterial partial pressure of carbon dioxide by using Sentri nasal cannula among sedated and non-sedated patient undergoing cataract surgery under local anaesthesia. Patients who are classified as ASA physical status 1 to 3 with age more than 18 years' old, and are scheduled for elective eye surgery in which arterial blood pressure monitoring is appropriate will be eligible. This study will be conducted at University Malaya Medical Centre.
Detailed description
After due approval from ethical review board and written consent, 40 patients who is scheduled for an elective eye procedure in which direct arterial blood pressure monitoring is appropriate will be recruited into this study. End tidal carbon dioxide will be sampled via SentriTM ETCO2 adult nasal cannula (Intersurgical ® code 1144002) during preoperative and intraoperative period. ETCO2 is measured by infrared spectroscopy (Datex-Ohmeda GE Healthcare S5, Compact monitor, Switzerland) with a side stream aspirator which has a flow rate of 150mL/min.
Standard monitoring with continuous electrography (ECG), non-invasive blood pressure(NIBP) monitoring and pulse oximetry will be used for all patients. A baseline blood pressure, heart rate, respiratory rate, oxygen saturation (SaO2) and ETCO2 will be recorded. During preoperative period, a 20-gauge, radial artery catheter was inserted under aseptic technique. It is used to obtain arterial blood gas measurement of partial pressure oxygen and carbon dioxide (PaO2, PaCO2) Blood gas will be analyzed by using ABL 800 flex blood gas analyzer (Radiometer Medical ApS, Denmark) with calibrations recommended by the manufacturer. No sedation will be given during preoperative period.
Following the placement of indwelling radial artery catheter, Sentri nasal cannula will be placed into the nostril of the patients Subjects will be asked to breath normally for a period of five minutes . Nasal breathing will be confirmed by presence of an acceptable CO2 tracing.Blood is drawn from indwelling arterial catheter for blood gas determination 5 minutes after the modified nasal cannulae is in place. At the same time as the arterial blood gas sample is taken, an ETCO2 sample is also obtained. A baseline (without oxygen flow) ETCO2, PaO2, SPO2, respiratory rate and PaCO2 will be recorded. The respiratory rate will be determined by counting the respiration for 15 seconds and multiplying by four. Subjects will not be asked to keep their mouth close when using the nasal cannula as it might alter the variability inherent in patients who mouth breathe during conscious sedation. After a baseline ETCO2 is established, oxygen will be administered at 2,4, and 6 liters per minute for a period of five minutes. At each level of oxygen administration, an average ETC02 reading will be recorded after achieving stable recordings. Simultaneously, PaO2 and PaCO2 will be obtained by drawing arterial blood from arterial indwelling catheter. Heart rate, respiratory rate, blood pressure will also be routinely recorded.
Sedation will be given to the patients intraoperatively. Riker Sedation-Agitation Scale (SAS) will be used to assess the level of sedation during intraoperative period. Titrated dose of midazolam will be given to the patient with the target of SAS score of 3 (difficult to arouse but awakens to verbal stimuli or gentle shaking, follow simple commands but drifts off again). During intraoperative period, oxygen will be administered at 2 and 4 liters per minutes for a period of five minutes. ETCO2, PaCO2 and PaO2 level will be recorded during each level of oxygen administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ETCO2 monitoring with nasal cannula | Experimental | Device: SentriTM ETCO2 adult nasal cannulaSentriTM ETCO2 adult nasal cannula (Intersurgical ® code 1144002) will be placed into patient's nostril following radial artery catheter insertion. A baseline (without oxygen flow) ETCO2, PaO2, SPO2, RR and PaCO2 will be recorded. Oxygen will then be administered at 2,4, and 6 liters per minute for a period of five minutes.ETCO2, PaCO2 and PaO2 will be recorded for each level of oxygen administration.Sedation will be given during intra-operative period with the target of Observer Assessment of alertness/sedation scale (OAA/S) score of 3. During intraoperative period, oxygen will be administered at 2 and 4 liters per minute for a period of five minutes. ETCO2, PaCO2 and PaO2 level will be recorded during each level of oxygen administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are classified as ASA (American Society of Anesthesiologist) physical status 1 to 3 with age more than 18 years' old, and are scheduled for elective eye surgery
Key exclusion criteria (1 listed)
- Patients who are less than 18 years old, have chronic lung disease, nasal obstruction, nasal congestion or craniofacial abnormalities
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 |
|---|---|---|
| SentriTM ETCO2 adult nasal cannulaSentri nasal cannula is the device which designed to sample exhaled ETCO2 in non-intubated patients during the administration of supplementary oxygen. By delivering oxygen through one prong and sampling exhaled gas from the other prong, the nasal cannula can provide end tidal values comparable to those achieved with intubated patients. It is fitted to the patients as same manner as conventional nasal cannula. Furthermore, it consists of curved prong to improve the anatomical fit. | Device | ETCO2 monitoring with nasal cannula |
Primary outcome
accuracy of end tidal carbon dioxide as a measure of arterial carbon dioxide levels by using Sentri cannula
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Ventilatory Depression
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Recruiting
The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia
Ventilatory Depression, Postoperative Respiratory Failure
Active, not recruitingObservational study
Personalizing Perioperative Analgesia in Children
Postoperative Pain
RecruitingObservational study
Phase Resolved Functional Lung MRI and Oscillometry for the Observation of Healthy Lung Function
Breathing, Lung Function Decreased
Not yet recruiting
Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline With the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)
Post Surgical Respiratory Failure, Respiratory Complication
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.
Questions about this trial
What is this clinical trial studying?
A study testing SentriTM ETCO2 adult nasal cannula in people with Ventilatory Depression, run by University of Malaya.
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: status not confirmed, as of the sponsor's last update on 15 Dec 2017. 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?
Results are not available in the source record.
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?
accuracy of end tidal carbon dioxide as a measure of arterial carbon dioxide levels by using Sentri cannula (time frame: 30 minutes). 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 15 Dec 2017.