Effects of Capnometry Monitoring in Post Anesthesia Care Unit (CAPNOSSPI)

There is few information about the best capnometry value in recovery room for intubated awakening patients. Furthermore, capnometry values could influence ventilation applied by nurses on these patients. The aim of this study is to observe the effects of capnometry monitoring on intubated awakening patients in recovery room.

Study Overview

• Status: Completed
• Conditions: Capnography; VENTILATION
• Intervention / Treatment: Device: CAPNOGRAPHY

Detailed Description

In France, there is actually no recommandation about capnography monitoring in recovery rooms. Nevertheless, some patients are still ventilated in post-anesthesia care units during awakening period. Alveolar hypoventilation could induce moderate hypercapnia, thereby stimulate central ventilatory command. However, this hypoventilation could delay the clearance of anesthetic gases. Capnometry monitoring could influence ventilation applied to these patients. Recovery rooms nurses would perform moderate hyperventilation in response to hign capnometry values. This method could enhance gases elimination, with faster spontaneous breathing recovery and extubation. Length of stay in recovery room could also be shortened. An objective surrogate of ventilation is maximal End Tidal CO2, if there is no alveolo-capillary gradient abnormality (Obesity, Chronic respiratory disease, Cyanogenic heart disease). Thus, this study will compare the percentage of patients who reached a maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care unit (PACU) in 2 groups :

• first group ("non-blind group") with capnography monitoring see by the PACU nurses
• second group ("blind group") with capnography monitoring but PACU nurses cannot see the values Other parameters like the time between ventilator's disconnection and the first ventilatory cycle in spontaneous ventilation, the time between ventilator's disconnection and tracheal extubation or laryngeal mask's withdrawal, the minimal SpO2 reached after tracheal extubation or laryngeal mask withdrawal or the length of stay in PACU are also recorded.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Centre Hospitalier Universitaire De Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Major patients with given written consent
• General anesthesia, induction with Propofol infusion and Target-Controlled Infusion (TCI) remifentanil, relayed with inhaled sevoflurane and TCI remifentanil
• Upper airway control with naso-orotracheal tube or laryngeal mask
• Ventilated normotherm patients in PACU

Exclusion Criteria:

• Minor or pregnant patients
• Obesity with Body Mass Index > 40 kg/m²
• Chronic respiratory disease with SpO2<90% in ambiant air
• Cyanogenic heart disease
• Patients under myorelaxant in PACU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAPNO+; END TIDAL CO2(EtCO2) is monitoring and PACU nurses can see the values delivered by the capnography device	Device: CAPNOGRAPHY; MONITORING OF CAPNOMETRY USING ETCO2 METHOD
No Intervention: CAPNO-; END TIDAL CO2(EtCO2) is monitoring but PACU nurses cannot see the values delivered by the capnography device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End Tidal CO2 up	Percentage of patients who reached a maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care unit (PACU)	through awakening period in PACU, an average of 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End Tidal CO2 max 1	Maximum EtCO2 reached before the first ventilatory cycle in spontaneaous ventilation	through awakening period in PACU, an average of 15 minutes
End Tidal CO2 max 2	Maximum EtCO2 reached after the first ventilatory cycle in spontaneous ventilation	through awakening period in PACU, an average of 30 minutes
respiratory rate	Respiratory rate applied by PACU nurse before the first ventilatory cycle in spontaneous ventilation	through awakening period in PACU, an average of 15 minutes
spontaneous ventilation time	Time (in minutes) between ventilator's disconnection and the first ventilatory cycle in spontaneous ventilation	through awakening period in PACU, an average of 15 minutes
time for removal of airway device	Time (in minutes) between ventilator's disconnection and tracheal extubation or laryngeal mask's withdrawal	through awakening period in PACU, an average of 30 minutes
Spo2 min	Minimal SpO2 after tracheal extubation or laryngeal mask withdrawal	through awakening period in PACU, an average of 2 hours
length of stay in PACU	Length of stay in PACU in minutes	through awakening period in PACU, an average of 2 hours
time for oxygenotherapy removal	Time (in minutes) between tracheal extubation or laryngeal mask withdrawal and oxygenotherapy weaning	through awakening period in PACU, an average of 1 hour

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Publications and helpful links

General Publications

• Potvin J, Etchebarne I, Soubiron L, Biais M, Roullet S, Nouette-Gaulain K. Effects of capnometry monitoring during recovery in the post-anaesthesia care unit: a randomized controlled trial in adults (CAPNOSSPI). J Clin Monit Comput. 2022 Apr;36(2):379-385. doi: 10.1007/s10877-021-00661-9. Epub 2021 Feb 7.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 14, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: ETCO2; Capnography; Post-anesthesia care unit; Capnometry; Recovery room
• Other Study ID Numbers: CHUBX2017/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No