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

NCT06824610 | Not Yet Recruiting

• 1 other identifier: use of capnography in sedation
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

• 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.

Conditions

Capnography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• peripheral O2 saturation

  baseline and every 5 minutes all through the procedure

Study Arms (3)

Group A

received 4 L /min oxygen flow rate.

Device: capnography

Group B

received 6 L /min oxygen flow rate.

Device: capnography

Group C

received 8 L /min oxygen flow rate.

Device: capnography

Interventions

capnography DEVICE

measurment of end-tidal carbon dioxide

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Related Publications (3)

• 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.

  PMID: 32556657 BACKGROUND

• 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.

  PMID: 31169549 BACKGROUND

• 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.

  PMID: 27565194 BACKGROUND

MeSH Terms

Interventions

Capnography

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Marina A Karam Lemoun, Master

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina A Karam Lemoun, Master

CONTACT

01030349115; 82400921@med.s-mu.edu.eg

Shimaa H Mohammed, MD

CONTACT

010 27026137; shimaa.hassan.mohamed@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Marina A. K. Lemoun

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 20, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share