Feasibility of Agitation Prevention Processes (APP) for adult mechanical ventilated patients: A prospective pilot study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900024179

Enrollment

Unknown

Registered

2019-06-29

Start date

2019-07-20

Completion date

Unknown

Last updated

2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

agitation

Interventions

Conventional light sedation group:Conventional light sedation

Agitation prevention processes group:Agitation Prevention Processes

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) aged >= 16 years; (2) body temperature (axillary temperature) >= 38.2 degree C; (3) septic shock + inhaled oxygen concentration >= 55% (PaO2 / FiO2 24 hours. Patients who match (1) + (2) + (4) or (1) + (3) + (4).

Exclusion criteria

Exclusion criteria: (1) pregnant or lactating women; (2) allergic to research medications or have other contraindications; (3) taking sedatives >= 1 month, opioid addicts; (4) patients with persistent epilepsy or GCS 48h); (7) patients after cardiopulmonary resuscitation; (8) patients who were not treated with beta blockers had a heart rate 24 hours, or patients who have undergone tracheotomy; (10) Patients with endotracheal intubation due to pathological airway obstruction or stenosis; (11) intemperant or alcohol dependent patients; (12) mental illness, dementia or other cognitive dysfunction; (13) drug users; (14) palliative treating patients; (15) dying patients; (16) patients or legal representatives refuse to sign informed consent .

Design outcomes

Primary

Measure	Time frame
Incidence of agitation within three days;Sedation strength (RASS score/number of evaluations)Within three days;	—

Secondary

Measure	Time frame
Patient recruitment rate (person/week);Start time of randomization;Cumulative use of analgesics and sedatives;First successful offline time (randomize start time to successful SBT);Time of successful extubation (at least 48h from randomization to removal of endotracheal tube);Accidental removal rate of medical devices;Incidence of deep sedation;Delirium incidence;The incidence of VAP;Non-mechanical ventilation time within 28 days after randomization;Tracheotomy rate;Rate of reintubation;ICU mortality and length of stay;Mortality within 28 days;	—

Measure

Time frame

Patient recruitment rate (person/week);Start time of randomization;Cumulative use of analgesics and sedatives;First successful offline time (randomize start time to successful SBT);Time of successful extubation (at least 48h from randomization to removal of endotracheal tube);Accidental removal rate of medical devices;Incidence of deep sedation;Delirium incidence;The incidence of VAP;Non-mechanical ventilation time within 28 days after randomization;Tracheotomy rate;Rate of reintubation;ICU mortality and length of stay;Mortality within 28 days;

—

Countries

China

Contacts

Public ContactPenglin Ma

The 8th Medical Center of Chinese PLA General Hospital

penglinma@163.com+86 13810339898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026