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60 post operative patients who are kept intubated overnight & are spontaneously breathing will be either supplied humidified oxygen Heated Humidifier(HH) or conventional mist nebulizer.
Temperature of inspired gas at the Y piece will be measured.
Sterile water will be used for HH & Mist nebuliser.
The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/ doctor/trained personnel and additional suctioning if required.
60 post operative patients who are kept intubated overnight & are spontaneously breathing will be selected in Tata Memorial Hospital (TMH), Mumbai. 30 patients will be supplied through humidified oxygen using FISHER & PAYKEL MR 370 Heated Humidifier(HH) & 30 patients through conventional mist nebulizer.
Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. Continuous monitoring of temperature will be done using standard monitor.
The reusable HH will be subjected to disinfection between patients. Sterile water will be used for HH & Mist nebuliser.
The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/ doctor/trained personnel.
Based on patient's clinical condition , additional suctioning will be done. Frequency of additional suctioning , reason for suctioning will be noted.
Information regarding the age, sex, type of surgery of the patient, co-morbidity if any size of ETT, the time of commencement of humidification , duration of use of humidifier, time of extubation, any complication leading to discontinuation of humidifier, frequency of refilling of nebulizer chamber, volume of ETT before intubation etc. will be noted.
The amount of Endotracheal tube blockade caused by secretion will be measured immediately following extubation.
The volume of Endotracheal tube secretion / amount of blockade will be assessed by the following process-
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heated humidifier group | Experimental | 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. |
|
| Mist humidifier group | Active Comparator | 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heated humidifier | Device | 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH) |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume | The bevel end & Murphy's eye of the Endotracheal tube was sealed using sterile insulating tape so that it becomes water tight. The tube was gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold was measured & noted | At baseline just before intubation and 24 hours from time of ICU admission |
| Assess the Increase in Nurses Work Load | Investigators will assess nursing workload by frequency of filling of humidifier chamber. | At baseline just before intubation and 24 hours from time of ICU admission |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Heated Humidifier Group | 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH) |
| FG001 | Mist Humidifier Group | 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Heated Humidifier Group | 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume | The bevel end & Murphy's eye of the Endotracheal tube was sealed using sterile insulating tape so that it becomes water tight. The tube was gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold was measured & noted | Posted | Mean | Standard Deviation | percentage change of ET tube volume | At baseline just before intubation and 24 hours from time of ICU admission |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heated Humidifier Group | 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using Heated Humidifier (HH). Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. heated humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Vijaya Patil | Tata Memorial Hospital, Mumbai | +91-2224177000 | 7048 | vijayappatil@yahoo.com |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| mist humidifier | Device | 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier |
|
| BG001 | Mist Humidifier Group | 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Mist Humidifier Group | 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier |
|
|
| Primary | Assess the Increase in Nurses Work Load | Investigators will assess nursing workload by frequency of filling of humidifier chamber. | The bevel end & Murphy's eye of the Endotracheal tube was sealed using sterile insulating tape so that it becomes water tight. The tube was gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold was measured & noted | Posted | Mean | Standard Deviation | time of refilling of nebuliser chamber | At baseline just before intubation and 24 hours from time of ICU admission |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Mist Humidifier Group | 30 postoperative patients with overnight endotracheal intubation will be supplied humidified oxygen using mist nebuliser. Temperature of inspired gas at the Y piece will be measured as surrogate marker for quality of humidification. The suctioning of ETT will be done once every 2 hourly by nurse/ doctor/trained personnel. mist humidifier: 30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier | 0 | 30 | 0 | 30 | 0 | 30 |
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