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CoughNCT04432701

Extubation in Pediatric Patients: Proactive or Passive?

A study testing proactive extubation in people with Cough and Tracheal Extubation, run by Eye & ENT Hospital of Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 3 to 7 years
Conditions the study is for
Cough, Tracheal Extubation
What is being tested?
proactive extubation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
10 Jul 2020to Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • American Society of Anesthesiologists physical status aged 3-7 years

Who cannot join

  • a suspected difficult airway reactive airway disease, recent upper respiratory tract infection gastrointestinal reflux obesity (body mass index>30 kg/m2

Trial locations and contacts

1 site in 1 country.

China1 site

  • Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

Official title: Which is the Better Choice for Extubation in Pediatric Patients: Proactive or Passive?

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).

Read the 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.

Being tested
proactive extubation
Keywords
passive, proactive, extubation, respiratory complication
Medical subject headings
Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • proactive extubationBehavioural

    when children is breathing spontaneously and adequately in PACU,endotracheal tube was removed directly

Study groups in NCT04432701
Study groupRoleWhat they receive
group AActive comparatorchildren were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex.
Receives: Behavioral: proactive extubation
group BNo interventionTracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coughing

    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.

    Measured: at the time of extubation within 1 minute

  2. Respiratory complications

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

    Measured: During the time when patients stayed in PACU after extubation, an average of 45 min

  3. Time to spontaneous eye opening

    Time to spontaneous eye opening

    Measured: The time from PACU arrival to spontaneous eye opening, an average of 45 min

  4. Time to discharge from PACU

    Time to discharge from PACU

    Measured: The time from patients arrived PACU to who was decided to discharge from PACU，an average of 1 hour

Secondary outcomes (14)

  1. Time to extubation

    The time of extubation after surgery

    Measured: The time from PACU arrival to tracheal extubation, an average of 30 min

  2. End-tidal concentration of minimum effective alveolar anesthetic concentration

    In percentage

    Measured: The time before patients were decided to extubate, within 1 minute

  3. Age

    In years

    Measured: 6 hours before intervention

  4. Weight

    In kilograms

    Measured: 6 hours before intervention

  5. Height

    In meters

    Measured: 6 hours before intervention

  6. Systolic blood pressure

    Hemodynamic parameter

    Measured: 5 minutes before extubation

  7. Systolic blood pressure

    Hemodynamic parameter

    Measured: 1 minute after extubation

  8. Systolic blood pressure

    Hemodynamic parameter

    Measured: 5 minutes after extubation

  9. Diastolic blood pressure

    Hemodynamic parameter

    Measured: 5 minutes before extubation

  10. Diastolic blood pressure

    Hemodynamic parameter

    Measured: 1 minute after extubation

  11. Diastolic blood pressure

    Hemodynamic parameter

    Measured: 5 minutes after extubation

  12. Heart rate

    hemodynamic parameter

    Measured: 5 minutes before extubation

  13. Heart rate

    hemodynamic parameter

    Measured: 1 minute after extubation

  14. Heart rate

    hemodynamic parameter

    Measured: 5 minutes after extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start10 Jul 2020
  3. Primary completion14 Dec 2020
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04432701
Sponsor's protocol ID
A/P extubation
Status last verified
Jan 2023
First submitted
3 May 2020
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tsukamoto M, Hitosugi T, Yokoyama T. Comparison of recovery in pediatric patients: a retrospective study. Clin Oral Investig. 2019 Sep;23(9):3653-3656. doi: 10.1007/s00784-019-02993-y. Epub 2019 Jul 4.

    PubMed 31273527

  • Bidwai AV, Bidwai VA, Rogers CR, Stanley TH. Blood-pressure and pulse-rate responses to endotracheal extubation with and without prior injection of lidocaine. Anesthesiology. 1979 Aug;51(2):171-3. doi: 10.1097/00000542-197908000-00020. No abstract available.

    PubMed 453622

  • Valley RD, Freid EB, Bailey AG, Kopp VJ, Georges LS, Fletcher J, Keifer A. Tracheal extubation of deeply anesthetized pediatric patients: a comparison of desflurane and sevoflurane. Anesth Analg. 2003 May;96(5):1320-1324. doi: 10.1213/01.ANE.0000058844.77403.16.

    PubMed 12707126

  • Gonzalez RM, Bjerke RJ, Drobycki T, Stapelfeldt WH, Green JM, Janowitz MJ, Clark M. Prevention of endotracheal tube-induced coughing during emergence from general anesthesia. Anesth Analg. 1994 Oct;79(4):792-5. doi: 10.1213/00000539-199410000-00030. No abstract available.

    PubMed 7943794

  • Fan Q, Hu C, Ye M, Shen X. Dexmedetomidine for tracheal extubation in deeply anesthetized adult patients after otologic surgery: a comparison with remifentanil. BMC Anesthesiol. 2015 Jul 23;15:106. doi: 10.1186/s12871-015-0088-7.

    PubMed 26202786

  • Inomata S, Yaguchi Y, Taguchi M, Toyooka H. End-tidal sevoflurane concentration for tracheal extubation (MACEX) in adults: comparison with isoflurane. Br J Anaesth. 1999 Jun;82(6):852-6. doi: 10.1093/bja/82.6.852.

    PubMed 10562778

Questions about this trial

What is this clinical trial studying?

A study testing proactive extubation in people with Cough and Tracheal Extubation, run by Eye & ENT Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coughing (time frame: at the time of extubation within 1 minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04432701, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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