NCT03374644

Brief Summary

Sampling end tidal gas via nasal prong has been shown to be a noninvasive and reliable method of monitoring end-tidal CO2 in spontaneously breathing patients. It is used to assess the adequacy of ventilation and enhance patient safety. When using a nasal cannula to sample expired gases by a patient, air from the room may dilute the sample and affect the accuracy of ETCO2. It is necessary to have accurate values of ETCO2 during intravenous sedation to detect respiratory depression including apnea. Therefore, the aim of our study is to assess the correlation of end tidal carbon dioxide to arterial partial pressure of carbon dioxide by using Sentri nasal cannula among sedated and non-sedated patient undergoing cataract surgery under local anaesthesia. Patients who are classified as ASA physical status 1 to 3 with age more than 18 years' old, and are scheduled for elective eye surgery in which arterial blood pressure monitoring is appropriate will be eligible. This study will be conducted at University Malaya Medical Centre.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

November 15, 2017

Last Update Submit

December 11, 2017

Conditions

Keywords

CorrelationETCO2PaCO2nasal cannulaSentri Nasal Cannula

Outcome Measures

Primary Outcomes (1)

  • accuracy of end tidal carbon dioxide as a measure of arterial carbon dioxide levels by using Sentri cannula

    30 minutes

Study Arms (1)

ETCO2 monitoring with nasal cannula

EXPERIMENTAL

SentriTM ETCO2 adult nasal cannula (Intersurgical ® code 1144002) will be placed into patient's nostril following radial artery catheter insertion. A baseline (without oxygen flow) ETCO2, PaO2, SPO2, RR and PaCO2 will be recorded. Oxygen will then be administered at 2,4, and 6 liters per minute for a period of five minutes.ETCO2, PaCO2 and PaO2 will be recorded for each level of oxygen administration.Sedation will be given during intra-operative period with the target of Observer Assessment of alertness/sedation scale (OAA/S) score of 3. During intraoperative period, oxygen will be administered at 2 and 4 liters per minute for a period of five minutes. ETCO2, PaCO2 and PaO2 level will be recorded during each level of oxygen administration.

Device: SentriTM ETCO2 adult nasal cannula

Interventions

Sentri nasal cannula is the device which designed to sample exhaled ETCO2 in non-intubated patients during the administration of supplementary oxygen. By delivering oxygen through one prong and sampling exhaled gas from the other prong, the nasal cannula can provide end tidal values comparable to those achieved with intubated patients. It is fitted to the patients as same manner as conventional nasal cannula. Furthermore, it consists of curved prong to improve the anatomical fit.

ETCO2 monitoring with nasal cannula

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are classified as ASA (American Society of Anesthesiologist) physical status 1 to 3 with age more than 18 years' old, and are scheduled for elective eye surgery

You may not qualify if:

  • Patients who are less than 18 years old, have chronic lung disease, nasal obstruction, nasal congestion or craniofacial abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical officer

Study Record Dates

First Submitted

November 15, 2017

First Posted

December 15, 2017

Study Start

January 15, 2018

Primary Completion

June 30, 2018

Study Completion

August 30, 2018

Last Updated

December 15, 2017

Record last verified: 2017-12