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A Comparison of the Detection of Hypoventilation During Deep Sedation Utilizing Nasal End Title CO@ Versus Transcutaneous CO2 Measurement Techniques

A Comparison of the Detection of Hypoventilation During Deep Sedation Utilizing Nasal End Title CO@ Versus Transcutaneous CO2 Measurement Techniques

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00954733
Enrollment
40
Registered
2009-08-07
Start date
2009-06-30
Completion date
2009-08-31
Last updated
2014-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoventilation, Surgery

Keywords

Hysteroscopic surgery, Hypoventilation, Co2, Transcutaneous Co2 Monitor

Brief summary

The estimation of the partial pressure of carbon dioxide (PCO2) in the arterial blood is used to judge the adequacy of ventilation during spontaneous and controlled ventilation. Although the gold standard for monitoring PCO2 remains arterial blood gas sampling, this requires an invasive procedure and provides only an intermittent estimate of what is frequently a continuously changing value. The solution to this problem has been the development and validation of accurate noninvasive monitoring techniques which provide a continuous intraoperative estimate of PCO2.The most commonly used noninvasive technique to monitor PCO2 is measurement of the end tidal CO2 (PECO2) . However, sampling errors and patient -related issues such as ventilation-perfusion mismatch, patient positioning or decreases in pulmonary blood flow may influence the accuracy of PECO2 monitoring (1-3). Nasal capnography has been proved to be an accurate monitor during the post-operative period (4) but its ability to accurately detect hypoventilation associated with deep sedation has not been studied. According to the American Society of Anesthesiologist standards for basic monitoring, continuous capnography is required for all patients undergoing general anesthesia but it is optional for MAC/sedation cases. The need for CO2 monitoring has been studied by other medical specialties that use procedural sedation, including gastroenterology (12) and emergency medicine (13, 14) and many specialties now recommend capnography as a standard monitor. Patients receiving supplemental oxygen may experience significant persistent hypoventilation leading to progressive hypercarbia and acidosis which may go undetected for a significant time interval since the routinely monitored SpO2 may be maintained within normal range. A recent study has shown that despite the fact that end tidal CO2 is reliable in detecting apnea , increasing oxygen flow rates decrease the amplitude of measured CO2, probably via dilution, making the quantitative value less reliable as an assessment of adequacy of ventilation (15). Furthermore, during hypoventilation there is reduced alveolar ventilation and the end tidal CO2 is not a true reflection of arterial CO2. Transcutaneous measurement of PCO2(PtcCO2) is a non-invasive method of measuring PCO2 that has been used much less frequently due to technical difficulties with earlier transcutaneous electrodes. Preliminary studies of the reliability of the current PtcCO2 electrodes (TOSCA, Linde Medical Sensors, and Basel, Switzerland) have shown good correlation of arterial and transcutaneous measurements in both adult volunteers and anesthetized subjects (5). PtcCO2 is measured with a sensor attached by a low pressure clip to an earlobe. The sensor probe heats the earlobe to 42 degrees Celsius to enhance blood flow. The current sensors have also been evaluated in anesthetized children (7, 8), anesthetized adults (9, 10) and critically ill neonates (11) and all these studies revealed a good correlation between PtCO2 and PaCO2.

Detailed description

A group of \_40 patients scheduled to undergo Hysteroscopy surgery with deep sedation will be studied. Standard monitors will be utilized. Additionally a transcutaneous CO2 electrode will be attached to the ear lobe and a BIS monitor will be applied to the forehead. The anesthetic management will be left to the discretion of the anesthesia provider (Anesthesia resident or CRNA, under the supervision of a faculty attending anesthesiologist).All patients will receive supplemental oxygen at 3L/ minute via nasal cannula, to maintain oxygen saturation greater than 90%. Both the end tidal CO2 (ETCO2) and transcutaneous CO2 (TcCO2) (Linde Medical Sensors, Basel , Switzerland ) will be calibrated before use, according to the manufacturer's instruction.. The anesthesia provider will be blinded to the TcCO2 monitor but will have access to the ETCO2 values. The ETCO2 and TcCO2 values will be recorded simultaneously by an independent observer. One arterial blood samples will be collected from each subject for measurement of PaCO2 at a deep level of sedation defined by a modified Ramsey score greater or equal to 5 (1= anxious/agitated/restless; 2= cooperative/oriented/tranquil; 3= drowsy/responds to commands only; 4= brisk response to shaking/loud sound; 5= sluggish response to shaking/loud sound; 6= no response) The ETCO2 and .TcCO2 will be recorded throughout the time of obtaining the blood sample every 15 seconds and the mean value will be used for comparison. Hypoventilation will be defined as a PaCO2 level greater than 45mmHg. Sedation score (OASS) will be recorded on admission to recovery area. Time to meet discharge criteria will be recorded. The experimental procedures: ABG draw, ETCO2 monitor placement on the ear, 2 Ramey scale assessments.

Interventions

One arterial blood draw

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age\>18 years of age * Sex: Non-pregnant, Female * ASA PS: I, II * Surgery: Elective Hysteroscopy surgery * Consent: Obtained

Exclusion criteria

* Age \< 18 years old * Patients who refuses participation * History of lung disease * History of Obstructive sleep apnea

Design outcomes

Primary

MeasureTime frameDescription
TcCo2 vs PACo2 Difference1 hourEvaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2

Countries

United States

Participant flow

Recruitment details

Subjects were approached in the pre operative area sequentially.

Participants by arm

ArmCount
All Participants
All participants in the study
40
Total40

Withdrawals & dropouts

PeriodReasonFG000
Overall Studyblood gas machine did not work1

Baseline characteristics

CharacteristicAll Participants
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
40 Participants
Age, Continuous42 years
Region of Enrollment
United States
40 participants
Sex: Female, Male
Female
40 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 40
serious
Total, serious adverse events
0 / 40

Outcome results

Primary

TcCo2 vs PACo2 Difference

Evaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2

Time frame: 1 hour

ArmMeasureValue (MEAN)Dispersion
All ParticipantsTcCo2 vs PACo2 Difference3.2 mmHGStandard Deviation 2.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026