Correlation of ETCO2 to PaCO2 Measured by Sentri Nasal Cannula

Ventilatory Depression Clinical Trial

Official title:

Correlation of End Tidal Carbon Dioxide to Arterial Partial Pressure Carbon Dioxide Measured by Sentri Nasal Cannula. A Study in Spontaneously Breathing Non Intubated Patients Undergoing Cataract Surgery With Local Anaesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03374644
• Other study ID #: 2017925-5591
• Status: Not yet recruiting
• Phase: N/A
• First received: November 15, 2017
• Last updated: December 11, 2017
• Start date: January 15, 2018
• Est. completion date: August 30, 2018

Study information

• Verified date: December 2017
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After due approval from ethical review board and written consent, 40 patients who is scheduled for an elective eye procedure in which direct arterial blood pressure monitoring is appropriate will be recruited into this study. End tidal carbon dioxide will be sampled via SentriTM ETCO2 adult nasal cannula (Intersurgical ® code 1144002) during preoperative and intraoperative period. ETCO2 is measured by infrared spectroscopy (Datex-Ohmeda GE Healthcare S5, Compact monitor, Switzerland) with a side stream aspirator which has a flow rate of 150mL/min.

Standard monitoring with continuous electrography (ECG), non-invasive blood pressure(NIBP) monitoring and pulse oximetry will be used for all patients. A baseline blood pressure, heart rate, respiratory rate, oxygen saturation (SaO2) and ETCO2 will be recorded. During preoperative period, a 20-gauge, radial artery catheter was inserted under aseptic technique. It is used to obtain arterial blood gas measurement of partial pressure oxygen and carbon dioxide (PaO2, PaCO2) Blood gas will be analyzed by using ABL 800 flex blood gas analyzer (Radiometer Medical ApS, Denmark) with calibrations recommended by the manufacturer. No sedation will be given during preoperative period.

Following the placement of indwelling radial artery catheter, Sentri nasal cannula will be placed into the nostril of the patients Subjects will be asked to breath normally for a period of five minutes . Nasal breathing will be confirmed by presence of an acceptable CO2 tracing.Blood is drawn from indwelling arterial catheter for blood gas determination 5 minutes after the modified nasal cannulae is in place. At the same time as the arterial blood gas sample is taken, an ETCO2 sample is also obtained. A baseline (without oxygen flow) ETCO2, PaO2, SPO2, respiratory rate and PaCO2 will be recorded. The respiratory rate will be determined by counting the respiration for 15 seconds and multiplying by four. Subjects will not be asked to keep their mouth close when using the nasal cannula as it might alter the variability inherent in patients who mouth breathe during conscious sedation. After a baseline ETCO2 is established, oxygen will be administered at 2,4, and 6 liters per minute for a period of five minutes. At each level of oxygen administration, an average ETC02 reading will be recorded after achieving stable recordings. Simultaneously, PaO2 and PaCO2 will be obtained by drawing arterial blood from arterial indwelling catheter. Heart rate, respiratory rate, blood pressure will also be routinely recorded.

Sedation will be given to the patients intraoperatively. Riker Sedation-Agitation Scale (SAS) will be used to assess the level of sedation during intraoperative period. Titrated dose of midazolam will be given to the patient with the target of SAS score of 3 (difficult to arouse but awakens to verbal stimuli or gentle shaking, follow simple commands but drifts off again). During intraoperative period, oxygen will be administered at 2 and 4 liters per minutes for a period of five minutes. ETCO2, PaCO2 and PaO2 level will be recorded during each level of oxygen administration.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Respiratory Insufficiency
• Ventilatory Depression

Intervention

Device:
• SentriTM ETCO2 adult nasal cannula
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of end tidal carbon dioxide as a measure of arterial carbon dioxide levels by using Sentri cannula		30 minutes