Trial · NCT06203405
The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
NCT06203405, Not applicable, Recruiting, Siriraj Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial. Trials, record NCT06203405. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06203405
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
- NCT number
- NCT06203405
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 214 participants, estimated
- Lead sponsor
- Siriraj Hospital
- Conditions
- Respiratory Failure, Critical Illness, Respiratory Distress Syndrome, Adult, Lung Injury, Mechanical Ventilation Complication
- Interventions
- Titrating sedation targeting both optimal P0.1 and appropriate arousal level, Fentanyl, Midazolam, Propofol, Dexmedetomidine, Cisatracurium
- First posted
- 2024-01-12
- Last updated
- 2025-05-22
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Successful extubation within 14 days after randomization | 14 days after randomization | Successful extubation within 14 days without reintubation within 28 days after ICU admission |
| Secondary | Successful extubation within 7 days after randomization | 7 days after randomization | Successful extubation within 7 days without reintubation within 28 days after ICU admission |
| Secondary | Successful extubation within 28 days after randomization | 28 days after randomization | Successful extubation without reintubation within 28 days after ICU admission |
| Secondary | Duration of mechanical ventilation | From date of intubation until the date of last successful extubation or date of death from any cause, whichever came first, assessed up to 28 days | Time from intubation to the last successful extubation |
| Secondary | Ventilator-free days to day 28 after randomization | 28 days after randomization | Number of days alive without mechanical ventilation |
| Secondary | Reintubation rate at 7 days after randomization | 7 days after randomization | Number of reintubation within 7 days after randomization |
| Secondary | Self extubation rate at 7 days after extubation | 7 days after randomization | Number of self extubation (accidentally extubation without physician's order) within 7 days after randomization |
| Secondary | Post-extubation respiratory failure | From date of randomization until the date of the first event of post-extubation respiratory failure or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days | Patients who meet at least one of the following criteria within 72 hours after extubation: respiratory rate more than 35 breaths/minute, oxygen saturation less than 90% or PaO2 less than 80 mmHg despite receiving FiO2 \>50%, respiratory acidosis with pH \<7.35 or PaCO2 \>50 mmHg or increase of 20% from baseline. |
| Secondary | Tracheostomy | From date of randomization until the date of tracheostomy or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days | Number of tracheostomy performed |
| Secondary | Lung injury score on day 3 after randomization | 3 days after randomization | Lung injury score on day 3 after randomization |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers37
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06203405
GET https://conductscience.org/api/trials/v1/NCT06203405/registered?page=2