- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04402320
Non Invasive and Invasive Ventilation Post Extubation
25 maggio 2020 aggiornato da: King Abdul Aziz Specialist Hospital
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
300
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Ta'if, Arabia Saudita, 21944
- King abd el Aziz specialist hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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
Descrizione
Inclusion Criteria:
- respiratory failure ARDS due to severe lung contusion
Exclusion Criteria:
- post arrest, deeply comatosed patients and children below 18 years
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Control group
extubated and weaning from the ventilator and followed our routine protocol of management post extubation without mechanical ventilation or BIPAP machine
|
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
Altri nomi:
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.
|
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
Altri nomi:
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.
|
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
Altri nomi:
reconnected to mechanical ventilation before extubation for one hour with sedation
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
number of patients re-intubated within 48 hours and shorten the duration of ICU stay
Lasso di tempo: 48 hours
|
monitoring hemodynamics, oxygenation, and conscious level in the studied duration
|
48 hours
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
10 aprile 2019
Completamento primario (Effettivo)
2 aprile 2020
Completamento dello studio (Effettivo)
20 aprile 2020
Date di iscrizione allo studio
Primo inviato
20 maggio 2020
Primo inviato che soddisfa i criteri di controllo qualità
20 maggio 2020
Primo Inserito (Effettivo)
26 maggio 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 maggio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 maggio 2020
Ultimo verificato
1 maggio 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Disturbi respiratori
- Segni e sintomi, respiratori
- Insufficienza respiratoria
- Ipossia
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Anestetici, per via endovenosa
- Anestetici, Generale
- Anestetici
- Agenti tranquillanti
- Psicofarmaci
- Ipnotici e sedativi
- Adiuvanti, Anestesia
- Agenti anti-ansia
- Modulatori GABA
- Agenti GABA
- Midazolam
Altri numeri di identificazione dello studio
- ICU-19-20
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Descrizione del piano IPD
see if both iv or niv after fullfilling the criteria of extubation in ARDS patients can prevent reintubation
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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