Non Invasive and Invasive Ventilation Post Extubation

NCT04402320 | Completed FDA Drug FDA Device

• 1 other identifier: ICU-19-20
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Patients and methods: It is a prospective double blind study done on total 300 patients. Admitted with respiratory failure ARDS due to severe lung contusion. All of them selected to be ventilated for one week or more. Patients were randomly allocated in one of three groups each group contain 100 patients. Group A considered control extubated and follow our routine protocol, patients of group B reconnected to mechanical ventilation before extubation for one hour. patients of Group C extubated and immediately connected to NIV with BIPAP mode for 1 hour every 12 hours for 24 hours. Results: There was significant reduction in the number of patients had deterioration in conscious level in all the duration of the study in patients of both groups B and C compared to group A. Also significant reduction in the number of patients had deterioration in clinical parameters of respiration in all the duration of the study in patients of both groups B and C compared to group A as regards high respiratory rate, desaturation and development of hyperdynamic circulation (tachycardia and hypertension). significant reduction in the number of patients had multiple quadrant parenchymatous infiltration in all the duration of the study in patients of both groups B and C compared to group A. significant reduction in the number of patients had marked limitation to FEV1, FVC and MVV in all the duration of the study in patients of both groups B and C compared to group A. Conclusion: Use of either NIV every 12 hours for 24 hours or MV for one hour after fulfillment of weaning criteria reduces reintubation and post-extubation respiratory failure and decrease the ICU stay in critically ill patients with resolving ARDS due to severe lung trauma.

Conditions

Respiratory Failure With Hypoxia

Keywords

non invasive ventilation invasive ventilation ARDS

Outcome Measures

Primary Outcomes (1)

• number of patients re-intubated within 48 hours and shorten the duration of ICU stay

  monitoring hemodynamics, oxygenation, and conscious level in the studied duration

  48 hours

Study Arms (3)

Control group

extubated and weaning from the ventilator and followed our routine protocol of management post extubation without mechanical ventilation or BIPAP machine

Drug: Midazolam; Device: ventilator

Invasive ventilation group

reconnected to mechanical ventilator before extubation for one hour with sedation with midazolam 3-5 milligram/hour intravenous infusion to achieve score 0 or -1on Richmond Agitation - Sedation Scale (RASS). 20 minutes before the end of this hour midazolam infusion discontinued and patients awaked. Patient put on mechanical ventilation (MV) with the following parameters, FIO2 40%, pressure SIMV mode, PEEP 8 cmH2O, Pressure support 15 cmH2O, Respiratory rate 14/min, Peak inspiratory pressure (PIP) of 35 cmH2O. Then patients extubated and followed our previous protocol without the use of NIV.

Drug: Midazolam; Device: ventilator

non invasive ventilation group

following the same previous protocol done after extubation with immediate connection to NIV with BIPAP mode for 1 hour and repeated every 12hours for 48 hours, BIPAP adjusted in our study by FIO2 40%, PEEP 8 cmH2O, Pressure support of 15 cmH2O.

Drug: Midazolam; Device: ventilator

Interventions

Midazolam DRUG

reconnected to mechanical ventilation before extubation for one hour with sedation with midazolam 3-5 milligram/hour intravenous infusion to achieve score 0 or -1on Richmond Agitation - Sedation Scale (RASS). 20 minutes before the end of this hour midazolam infusion discontinued and patients awaked. Patient put on mechanical ventilation (MV) with the following parameters, FIO2 40%, pressure SIMV mode, PEEP 8 cmH2O, Pressure support 15 cmH2O, Respiratory rate 14/min, Peak inspiratory pressure (PIP) of 35 cmH2O. Then patients extubated and followed our previous protocol without the use

Also known as: dormicum

Control group; Invasive ventilation group; non invasive ventilation group

ventilator DEVICE

reconnected to mechanical ventilation before extubation for one hour with sedation

Control group; Invasive ventilation group; non invasive ventilation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: adult only 18-65 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

on total 300 patients. Admitted to King Abdulaziz specialist hospital in Taif, KSA. Between April 2019 and April 2020 with respiratory failure ARDS due to severe lung contusion with these criteria: hypoxic index less than 200, bilateral parenchymatous lung infiltrate, no any acute cardiac insult, failed to maintain SPO2 more than 90% with Non-Invasive Ventilation (NIV) or need of continuous NIV to maintain the previous saturation. This selected ARDS was due to lung contusion which diagnosed by Computerized tomography of the chest following chest trauma. All of them selected to be ventilated for one week or more and only those who showed full criteria of weaning from the ventilator enrolled in our study

You may qualify if:

• respiratory failure ARDS due to severe lung contusion

You may not qualify if:

• post arrest, deeply comatosed patients and children below 18 years

Sponsors & Collaborators

• King Abdul Aziz Specialist Hospital: lead

Study Sites (1)

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

Location

MeSH Terms

Interventions

Midazolam; Ventilators, Mechanical

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: April 10, 2019
• Primary Completion: April 2, 2020
• Study Completion: April 20, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)