The Effectivity of End-tidal CO2 and Oxygen Reserve Index (ORI) Monitoring in Sedation

NCT04793178 | Completed

• 1 other identifier: YuksekIhtisasH
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endoscopic procedures are commonly performed using sedation. As drug-induced respiratory depression is a major cause of sedation-related morbidity, pulse oximetry has been established as standart practice . However SpO2 does not completely reflect ventilation. Capnography is an additional monitoring parameter which demonstrates respiration activity breath by breath. Unfortunately, in the state of moderate or deep sedation during diagnostic or therapeutic procedures (e.g.ERCP or colonoscopies), regular breathing is often disturbed by moving, squeezing, coughing or changes between nose and mouth ventilation causing leakage and therefore artifacts or misinterpretation of data acquired with ETCO2. These problems often restrict the use of side-stream capnography in clinical practice, although the American Society of Anesthesiologists have suggested in their guidelines that extended monitoring with capnography 'should be considered'in deep sedation. The oxygen reserve index (ORI) is a new feature of multiple wavelength pulse oximetry that provides real-time visibility to oxygenation status in the moderate hyperoxic range (PaO2 of approximately 100-200 mm Hg). The ORI is an "index" with a unit-less scale between 0.00 and 1.00 that can be trended and has optional alarms to notify clinicians of changes in a patient's oxygen status. When utilized in conjunction with SpO2 monitoring the ORI may extend the visibility of a patient's oxygen status into ranges previously unmonitored in this fashion. The ORI may make pre-oxygenation visible, may provide early warning when oxygenation deteriorates, and may facilitate a more precise setting of the required FiO2 level. In this study we aimed to show effectivity of capnography and ORİ monitoring to avoid respiratory events and hypoxia in sedated endoscopic patients. In this study we targeted totally 300 sedated endoscopy patients. Patients will randomize to two groups. In Group I anaesthesiologis will be able to use all the monitoring, where as in Group II will be blinded for ORİ. We will apply pre-oxygenation to obtain long safe apnea time. Approximately 5 min pre-oxygenation (5L/min via nasal cannula) will be used to reach steady state in oxygen reserve. We defined hypoxemia ; SpO2\<95% and severe hypoxemia SpO2≤90%, hypoventilation; rise10 mmHg in ETCO2 compare to baseline, ETCO2≤30 mmHg and flat capnography.

Conditions

Hypoxemia; Procedural Sedation; Hypercapnia; Apnea

Keywords

sedation, end-tidal carbon dioxide, oxygen reserve index

Outcome Measures

Primary Outcomes (2)

• Hypoxemia

  SpO2\<95%

  during the procedure when/if occured

• Severe hypoxemia

  SpO2≤90%,

  during the procedure when/if occured

Secondary Outcomes (2)

• hypoventilation

  during the procedure when/if occured

• low oxygen reserve index

  during the procedure when/if occured

Study Arms (2)

Oxygen Reserve Index Blinded Group

ACTIVE COMPARATOR

Aneshesist will be blinded for oxygen reserve index monitoring (ORI, Masimo Corporation), but he will be allowed to use pulse oxymetry and end-tidal carbon dioxide monitoring to manage the respiratory conditions and depth of sedation.

Device: Oxygen Reserve Index, Masimo Corporation, USA.

Oxygen Reserve Index Group

EXPERIMENTAL

Aneshesist will be allowed to use pulse oxymetry, end-tidal carbon dioxide and oxygen reserve index (ORI) monitoring. He will manage the depth of sedation, respiaratory conditions.

Device: Oxygen Reserve Index, Masimo Corporation, USA.

Interventions

Oxygen Reserve Index, Masimo Corporation, USA. DEVICE

The oxygen reserve index (ORI) is a new feature of multiple wavelength pulse oximetry that provides real-time visibility to oxygenation status in the moderate hyperoxic range (PaO2 of approximately 100-200 mm Hg).

Oxygen Reserve Index Blinded Group; Oxygen Reserve Index Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with age between 18-75 who are scheduled for endoscopic procedures under moderate or deep sedation, in Türkiye Yüksek İhtisas Training and Research Hospital.

You may not qualify if:

• Patient who refuse to concent. 2- Hepatic disease, e.g. twice the normal level of liver enzymes. 3- EF\<40%.

Sponsors & Collaborators

• Yuksek Ihtisas Hospital: lead

Related Publications (2)

• Merry AF, Cooper JB, Soyannwo O, Wilson IH, Eichhorn JH. International Standards for a Safe Practice of Anesthesia 2010. Can J Anaesth. 2010 Nov;57(11):1027-34. doi: 10.1007/s12630-010-9381-6. Epub 2010 Sep 21. No abstract available.

  PMID: 20857254 RESULT

• Sacchetti A, Senula G, Strickland J, Dubin R. Procedural sedation in the community emergency department: initial results of the ProSCED registry. Acad Emerg Med. 2007 Jan;14(1):41-6. doi: 10.1197/j.aem.2006.05.023. Epub 2006 Aug 31.

  PMID: 16946280 RESULT

MeSH Terms

Conditions

Hypoxia; Hypercapnia; Apnea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and assessor are blinded to study arms.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: March 11, 2021
• Study Start: December 25, 2015
• Primary Completion: May 25, 2016
• Study Completion: March 1, 2017
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share