Extubation in Pediatric Patients: Proactive or Passive?

Sponsor
Eye & ENT Hospital of Fudan University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04432701
Collaborator
(none)
60
1
2
20.7
2.9

Study Details

Study Description

Brief Summary

Smooth extubation process can reduce the complications in recovery time. This study aimed to investigate what is the better time to extubation when children is breathing spontaneously and adequately: waiting until children have movements or wakefulness (passive extubation)or removing endotracheal tube directly (proactive tracheal extubation).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: proactive extubation
N/A

Detailed Description

This is a randomized, controlled cross-over trial. The hypothesis of this study is that the different extubation protocol can impact recovery quality in children in post-anaesthesia care unit (PACU). Patients aged 3-7 years were randomized into two equal groups: proactive extubation (Group A) and passive extubation. At the end of surgery, sevoflurane was turned off and patients all delivered into PACU for recovery. Patient was positioned on his or her lateral side. The ventilation was switched to positive airway pressure (CPAP) mode once the patients regained spontaneous respiration. After spontaneous breathing turn to regular and sufficient(tidal volume >6-8 ml/kg, respiratory rate >10 times per minutes , end tidal carbon dioxide concentration >7.19 mmHg), the trachea tube could be removed. In Group A, patients were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex. In Group B, tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement. After extubation, 2 L/min oxygen was administered with Venturi face mask for 10 min in both groups. Patients were transported to the ward until they breathed air with a patent airway. The extubation time, recovery characteristics and respiratory complication were recorded.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Which is the Better Choice for Extubation in Pediatric Patients: Proactive or Passive?
Actual Study Start Date :
Jul 10, 2020
Actual Primary Completion Date :
Dec 14, 2020
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: group A

children were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex.

Behavioral: proactive extubation
when children is breathing spontaneously and adequately in PACU,endotracheal tube was removed directly

No Intervention: group B

Tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement.

Outcome Measures

Primary Outcome Measures

  1. Coughing [at the time of extubation within 1 minute]

    1 if a single cough occurred and saturation by pulse oximetry (SpO2) ≥95%; 2 if multiple coughs occurred and SpO2 ≥95%; 3 if multiple coughs occurred and SpO2 <95%; and 4 if multiple coughs occurred, SpO2 <95%, and coughing required administration of i.v . medication.

  2. Respiratory complications [During the time when patients stayed in PACU after extubation, an average of 45 min]

    the number of patients who had gagging, clenched teeth, gross purposeful movements, breath holding, laryngospasm, or desaturation to SpO2<90%

  3. Time to spontaneous eye opening [The time from PACU arrival to spontaneous eye opening, an average of 45 min]

    Time to spontaneous eye opening

  4. Time to discharge from PACU [The time from patients arrived PACU to who was decided to discharge from PACU,an average of 1 hour]

    Time to discharge from PACU

Secondary Outcome Measures

  1. Time to extubation [The time from PACU arrival to tracheal extubation, an average of 30 min]

    The time of extubation after surgery

  2. End-tidal concentration of minimum effective alveolar anesthetic concentration [The time before patients were decided to extubate, within 1 minute]

    In percentage

  3. Age [6 hours before intervention]

    In years

  4. Weight [6 hours before intervention]

    In kilograms

  5. Height [6 hours before intervention]

    In meters

  6. Systolic blood pressure [5 minutes before extubation]

    Hemodynamic parameter

  7. Systolic blood pressure [1 minute after extubation]

    Hemodynamic parameter

  8. Systolic blood pressure [5 minutes after extubation]

    Hemodynamic parameter

  9. Diastolic blood pressure [5 minutes before extubation]

    Hemodynamic parameter

  10. Diastolic blood pressure [1 minute after extubation]

    Hemodynamic parameter

  11. Diastolic blood pressure [5 minutes after extubation]

    Hemodynamic parameter

  12. Heart rate [5 minutes before extubation]

    hemodynamic parameter

  13. Heart rate [1 minute after extubation]

    hemodynamic parameter

  14. Heart rate [5 minutes after extubation]

    hemodynamic parameter

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • American Society of Anesthesiologists physical status aged 3-7 years
Exclusion Criteria:
  • a suspected difficult airway reactive airway disease, recent upper respiratory tract infection gastrointestinal reflux obesity (body mass index>30 kg/m2

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University Shanghai Shanghai China 200031

Sponsors and Collaborators

  • Eye & ENT Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT04432701
Other Study ID Numbers:
  • A/P extubation
First Posted:
Jun 16, 2020
Last Update Posted:
Mar 28, 2022
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Eye & ENT Hospital of Fudan University

Study Results

No Results Posted as of Mar 28, 2022