The Effect of Oxygen Flow Rate on End-tidal CO2 During Deep Sedation

NCT ID: NCT06824610

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-09-20

Brief Summary

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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

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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

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Capnography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

received 4 L /min oxygen flow rate.

capnography

Intervention Type DEVICE

measurment of end-tidal carbon dioxide

Group B

received 6 L /min oxygen flow rate.

capnography

Intervention Type DEVICE

measurment of end-tidal carbon dioxide

Group C

received 8 L /min oxygen flow rate.

capnography

Intervention Type DEVICE

measurment of end-tidal carbon dioxide

Interventions

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capnography

measurment of end-tidal carbon dioxide

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient aged 18-45 years
2. ASA physical status l : ll
3. Minor elective gynaecological procedures lasting less than 30 minutes ( D\&C biopsy, hysteroscopic polypectomy and diagnostic hysteroscopy )

Exclusion Criteria

* We will exclude from the study patients with the following:

1. Patient refusal to participate in this study.
2. ASA lll or more.
3. Lengthy procedures taking more than 30 minutes
4. Contraindication for the use of laryngeal mask airway as ( pharyngeal pathology, risk of aspiration and airway obstruction below larynx)
5. BMI more than 35
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Marina Adel Karam Lemoun

Principal Investigator Marina A. K. Lemoun

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marina A Karam Lemoun, Master

Role: PRINCIPAL_INVESTIGATOR

Minia University

Central Contacts

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Marina A Karam Lemoun, Master

Role: CONTACT

01030349115 ext. +20

Shimaa H Mohammed, MD

Role: CONTACT

010 27026137 ext. +20

References

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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.

Reference Type BACKGROUND
PMID: 32556657 (View on PubMed)

Wadhwa 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.

Reference Type BACKGROUND
PMID: 31169549 (View on PubMed)

Dewdney 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.

Reference Type BACKGROUND
PMID: 27565194 (View on PubMed)

Other Identifiers

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use of capnography in sedation

Identifier Type: -

Identifier Source: org_study_id

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