NCT03370081

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

December 4, 2017

Last Update Submit

October 14, 2018

Conditions

VENTILATIONCapnography

Keywords

CapnometryCapnographyETCO2Recovery roomPost-anesthesia care unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • End Tidal CO2 max 1

    through awakening period in PACU, an average of 15 minutes

  • End Tidal CO2 max 2

    through awakening period in PACU, an average of 30 minutes

  • respiratory rate

    through awakening period in PACU, an average of 15 minutes

  • spontaneous ventilation time

    through awakening period in PACU, an average of 15 minutes

  • time for removal of airway device

    through awakening period in PACU, an average of 30 minutes

  • +3 more secondary outcomes

Study Arms (2)

CAPNO+

EXPERIMENTAL

END TIDAL CO2(EtCO2) is monitoring and PACU nurses can see the values delivered by the capnography device

Device: CAPNOGRAPHY

CAPNO-

NO INTERVENTION

END TIDAL CO2(EtCO2) is monitoring but PACU nurses cannot see the values delivered by the capnography device

Interventions

CAPNOGRAPHYDEVICE

MONITORING OF CAPNOMETRY USING ETCO2 METHOD

CAPNO+

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier Universitaire de Bordeaux

Bordeaux, 33076, France

Location

Related Publications (1)

  • 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.

    PMID: 33550546DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Capnography

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D; PH.D. Head of department, Anesthesiology and ICU, clinical professor

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 12, 2017

Study Start

January 15, 2018

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

FR(1)