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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Capnography
• Intervention / Treatment: Device: capnography

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Marina A Karam Lemoun, Master; Phone Number: +20 01030349115; Email: 82400921@med.s-mu.edu.eg
• Study Contact Backup: Name: Shimaa H Mohammed, MD; Phone Number: +20 010 27026137; Email: shimaa.hassan.mohamed@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

females aged between18 - 45 years old scheduled for minor gynaecological procedures under deep sedation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; received 4 L /min oxygen flow rate.	Device: capnography; measurment of end-tidal carbon dioxide
Group B; received 6 L /min oxygen flow rate.	Device: capnography; measurment of end-tidal carbon dioxide
Group C; received 8 L /min oxygen flow rate.	Device: capnography; measurment of end-tidal carbon dioxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
carbon dioxide monitoring	Primary outcome is measuring end tidal carbon dioxide ( EtCO2 ) non invasively by laryngeal mask all through the procedure.	baseline and every 5 minutes all through the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peripheral O2 saturation	peripheral O2 saturation	baseline and every 5 minutes all through the procedure

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Marina A Karam Lemoun, Master, Minia University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 20, 2025

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: use of capnography in sedation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data is available with a corresponding author on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No