Non Invasive and Invasive Ventilation Post Extubation

Comparative Study Between Usage of NIV Versus MV for One Hour After Fulfillment of Weaning Criteria From Ventilation on Re-intubation in Post-traumatic ARDS

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure With Hypoxia
• Intervention / Treatment: Drug: Midazolam; Device: ventilator

Detailed Description

It is a prospective double-blind study done 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. Our criteria of weaning include fully conscious patients, hemodynamically stable without any inotropic support, hypoxic index(PAO2/FIO2) more than 200 calculated from the arterial blood gases (ABG), bicarbonate level in arterial blood more than 20 mmol/l, hemoglobin level more than 10 gm%, chest X ray less than one quadrant parenchymatous infiltration in each lung on Murray score of chest Xray, rapid shallow breathing index <105. Patients were randomly allocated in one of three groups each group contain 100 patients. Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of randomization can be expressed at the same time. Patients of group A extubated and followed our routine protocol of management post extubation which include Nebulization with Ventolin and epinephrine racemic every 8 hours for 48 hours, chest physical therapy (CPT) every 6 hours for 48 hours include clapping percussion with mechanical vibration and suction plus huffing or coughing and postural drainage if there was atelectasis seen by our routine chest X ray. Patients of group B 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 of NIV.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Saudi Arabia
  • Ta'if, Saudi Arabia, 21944
    • King abd el Aziz specialist hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• respiratory failure ARDS due to severe lung contusion

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Other Names: dormicum; Device: ventilator; reconnected to mechanical ventilation before extubation for one hour with sedation
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; 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; Other Names: dormicum; Device: ventilator; reconnected to mechanical ventilation before extubation for one hour with sedation
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; 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; Other Names: dormicum; Device: ventilator; reconnected to mechanical ventilation before extubation for one hour with sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King Abdul Aziz Specialist Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): April 2, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: non invasive ventilation invasive ventilation ARDS
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: ICU-19-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: see if both iv or niv after fullfilling the criteria of extubation in ARDS patients can prevent reintubation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No