CapnographyNCT06824610
The Effect of Oxygen Flow Rate on End-tidal CO2 During Deep Sedation
An observational study of Capnography, run by Minia University.
Trial summary
This study aims to detect the effect of different O2 flow rates on end tidal carbon dioxide level in patients scheduled for minor gynaecological procedures under deep sedation using laryngeal mask airway. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Capnography
- What is being tested?
- capnography
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 20 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: females aged between18 - 45 years old scheduled for minor gynaecological procedures under deep sedation
Who may be able to join
- Patient aged 18-45 years
- ASA physical status l : ll
- Minor elective gynaecological procedures lasting less than 30 minutes ( D\&C biopsy, hysteroscopic polypectomy and diagnostic hysteroscopy )
Who cannot join
- We will exclude from the study patients with the following:
- Patient refusal to participate in this study.
- ASA lll or more.
- Lengthy procedures taking more than 30 minutes
- Contraindication for the use of laryngeal mask airway as ( pharyngeal pathology, risk of aspiration and airway obstruction below larynx)
- BMI more than 35
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Different Oxygen Flow Rates on End-tidal Carbon Dioxide Monitoring During Procedural Sedation in Patients Undergoing Minor Gynaecological Procedures.
This study aims to detect the effect of different O2 flow rates on end tidal carbon dioxide level in patients scheduled for minor gynaecological procedures under deep sedation using laryngeal mask airway.
- Primary outcome was measuring end tidal carbon dioxide ( EtCO2 ) non invasively by laryngeal mask all through the procedure.
- Secondary outcomes included peripheral O2 saturation, hemodynamics, time to recovery, total propofol dose, patients' satisfaction, sedation score, and complications.
Read the detailed description
Procedural sedation (PS) is generally considered to include the stages of moderate and deep sedation of the continuum of anaesthesia . The clinical goals of procedural sedation are to alleviate apprehension, ameliorate the examination, findings, minimize the patients' memories of the incident and to control pain and distress during diagnostic and interventional medical procedures a lot of minor gynaecological procedures can be performed under moderate to deep sedation as ( D\&C Biopsy, hysteroscopic polypectomy and diagnostic hysteroscopies ) The greatest threat to the safety of sedated patient is airway compromise and or respiratory depression . To decrease the risk of airway and respiratory complications, careful attention must be directed toward the appropriate selection of medications, adherence to dosing recommendations, and most importantly the identification of the high-risk patient.
Regardless of the clinical scenario or the medications used, appropriate monitoring of the patient's respiratory and physiologic functions is mandatory to rapidly identify respiratory compromise.
Respiratory function is usually evaluated by observation of qualitative clinical signs (respiratory rate, depth and effort) and oxygen saturation monitoring. Oxygen desaturation in pulse oximetry usually occurs as a delayed sign , so if the capnograph monitor is used, any increase in EtCO2 during hypoventilation can alert the observing anesthetist to avoid hypoxemia. Capnography is a respiratory monitoring device that has become an accepted standard of care for PS in many circumstances. So, the American Society of Anesthesiology standards for Basic Anesthetic Monitoring require the use of capnography for both moderate and deep sedation.
- Conditions
- Capnography
- Being tested
- capnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capnographyDevice
measurment of end-tidal carbon dioxide
| Study group | Role | What they receive |
|---|---|---|
| Group A | received 4 L /min oxygen flow rate. Receives: Device: capnography | |
| Group B | received 6 L /min oxygen flow rate. Receives: Device: capnography | |
| Group C | received 8 L /min oxygen flow rate. Receives: Device: capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
carbon dioxide monitoring
Primary outcome is measuring end tidal carbon dioxide ( EtCO2 ) non invasively by laryngeal mask all through the procedure.
Measured: baseline and every 5 minutes all through the procedure
Secondary outcomes (1)
peripheral O2 saturation
peripheral O2 saturation
Measured: baseline and every 5 minutes all through the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CapnographyStudies of the same condition, open and under way.
- More trials run by Minia 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Adel Karam Lemoun, Minia University
- Investigators
- Marina A Karam Lemoun, Master, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824610
- Sponsor's protocol ID
- use of capnography in sedation
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available with a corresponding author on reasonable request
Publications
Askar H, Misch J, Chen Z, Chadha S, Wang HL. Capnography monitoring in procedural intravenous sedation: a systematic review and meta-analysis. Clin Oral Investig. 2020 Nov;24(11):3761-3770. doi: 10.1007/s00784-020-03395-1. Epub 2020 Jun 16.
PubMed 32556657Wadhwa V, Gupta K, Vargo JJ. Monitoring standards in sedation and analgesia: the odyssey of capnography in sedation for gastroenterology procedures. Curr Opin Anaesthesiol. 2019 Aug;32(4):453-456. doi: 10.1097/ACO.0000000000000756.
PubMed 31169549Dewdney C, MacDougall M, Blackburn R, Lloyd G, Gray A. Capnography for procedural sedation in the ED: a systematic review. Emerg Med J. 2017 Jul;34(7):476-484. doi: 10.1136/emermed-2015-204944. Epub 2016 Aug 26.
PubMed 27565194
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Oxygen Flow Rates on End-tidal Carbon Dioxide Monitoring During Procedural Sedation in Patients Undergoing Minor Gynaecological Procedures.
- ClinicalTrials.gov ID
- NCT06824610
- Acronym / sponsor ID
- use of capnography in sedation
- Conditions
- Capnography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 13 Feb 2025 (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.
This study aims to detect the effect of different O2 flow rates on end tidal carbon dioxide level in patients scheduled for minor gynaecological procedures under deep sedation using laryngeal mask airway.
- Primary outcome was measuring end tidal carbon dioxide ( EtCO2 ) non invasively by laryngeal mask all through the procedure.
- Secondary outcomes included peripheral O2 saturation, hemodynamics, time to recovery, total propofol dose, patients' satisfaction, sedation score, and complications.
Detailed description
Procedural sedation (PS) is generally considered to include the stages of moderate and deep sedation of the continuum of anaesthesia . The clinical goals of procedural sedation are to alleviate apprehension, ameliorate the examination, findings, minimize the patients' memories of the incident and to control pain and distress during diagnostic and interventional medical procedures a lot of minor gynaecological procedures can be performed under moderate to deep sedation as ( D\&C Biopsy, hysteroscopic polypectomy and diagnostic hysteroscopies ) The greatest threat to the safety of sedated patient is airway compromise and or respiratory depression . To decrease the risk of airway and respiratory complications, careful attention must be directed toward the appropriate selection of medications, adherence to dosing recommendations, and most importantly the identification of the high-risk patient.
Regardless of the clinical scenario or the medications used, appropriate monitoring of the patient's respiratory and physiologic functions is mandatory to rapidly identify respiratory compromise.
Respiratory function is usually evaluated by observation of qualitative clinical signs (respiratory rate, depth and effort) and oxygen saturation monitoring. Oxygen desaturation in pulse oximetry usually occurs as a delayed sign , so if the capnograph monitor is used, any increase in EtCO2 during hypoventilation can alert the observing anesthetist to avoid hypoxemia. Capnography is a respiratory monitoring device that has become an accepted standard of care for PS in many circumstances. So, the American Society of Anesthesiology standards for Basic Anesthetic Monitoring require the use of capnography for both moderate and deep sedation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: capnographyreceived 4 L /min oxygen flow rate. |
| Group B | – | Device: capnographyreceived 6 L /min oxygen flow rate. |
| Group C | – | Device: capnographyreceived 8 L /min oxygen flow rate. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- females aged between18 - 45 years old scheduled for minor gynaecological procedures under deep sedation
Key inclusion criteria (3 listed)
- Patient aged 18-45 years
- ASA physical status l : ll
- Minor elective gynaecological procedures lasting less than 30 minutes ( D\&C biopsy, hysteroscopic polypectomy and diagnostic hysteroscopy )
Key exclusion criteria (6 listed)
- We will exclude from the study patients with the following:
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 |
|---|---|---|
| capnographymeasurment of end-tidal carbon dioxide | Device | Group A, Group B, Group C |
Primary outcome
carbon dioxide monitoring
Time frame: baseline and every 5 minutes all through the procedure
Primary outcome is measuring end tidal carbon dioxide ( EtCO2 ) non invasively by laryngeal mask all through the procedure.
1 secondary outcome
peripheral O2 saturation
Time frame: baseline and every 5 minutes all through the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Background: PubMed 32556657Askar H, Misch J, Chen Z, Chadha S, Wang HL. Capnography monitoring in procedural intravenous sedation: a systematic review and meta-analysis. Clin Oral Investig. 2020 Nov;24(11):3761-3770. doi: 10.1007/s00784-020-03395-1. Epub 2020 Jun 16.
- Background: PubMed 31169549Wadhwa V, Gupta K, Vargo JJ. Monitoring standards in sedation and analgesia: the odyssey of capnography in sedation for gastroenterology procedures. Curr Opin Anaesthesiol. 2019 Aug;32(4):453-456. doi: 10.1097/ACO.0000000000000756.
- Background: PubMed 27565194Dewdney C, MacDougall M, Blackburn R, Lloyd G, Gray A. Capnography for procedural sedation in the ED: a systematic review. Emerg Med J. 2017 Jul;34(7):476-484. doi: 10.1136/emermed-2015-204944. Epub 2016 Aug 26.
- Individual participant dataSharing planned: No. Data is available with a corresponding author on reasonable request
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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.
Marina A Karam Lemoun, Master principal investigator
Minia University
Questions about this trial
What is this clinical trial studying?
An observational study of Capnography, run by Minia University.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 14 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina A Karam Lemoun, Master (01030349115 ext. +20, 82400921@med.s-mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carbon dioxide monitoring (time frame: baseline and every 5 minutes all through the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06824610, which also lists 3 linked publications.
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 14 Feb 2025.