Cancer of Head and Neck
Conditions
Brief summary
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.
Detailed description
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- * The bevel end & Murphy's eye of the Endotracheal tube will be sealed using sterile insulating tape so that it become water tight. The tube will be 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 will be measured & noted. * The volume of extubated tube will be measured in the similar way. * The measured volume of the Extubated Endotracheal tube will be subtracted from the actual volume of the particular Sized ETT ( measured before intubation). * The result obtained after this subtraction will be the volume of secretion or the volume of ETT that has been blocked.
Interventions
DEVICEheated humidifier
30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)
DEVICEmist humidifier
30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier
Sponsors
Tata Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anaesthesiologists (ASA) 1 and 2 adult Patients 2. Undergoing surgery for head and neck cancer 3. Requiring overnight endotracheal tube & breathing spontaneously
Exclusion criteria
1. Patients with major cardiac diseases( coronary artery disease, Valvular diseases) 2. Patients having gross chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, cystic fibrosis. 3. Smokers(abstinence period less than 3 months) 4. Patient in drugs having sialogogue properties. 5. Patient on drugs having anti-sialogogue properties
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume | At baseline just before intubation and 24 hours from time of ICU admission | 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 |
| Assess the Increase in Nurses Work Load | At baseline just before intubation and 24 hours from time of ICU admission | Investigators will assess nursing workload by frequency of filling of humidifier chamber. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 30 |
| 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 | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Mist Humidifier Group | Total | Heated Humidifier Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 18 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 42 Participants | 22 Participants |
| Age, Continuous | 50.60 years STANDARD_DEVIATION 11.6 | 49.58 years STANDARD_DEVIATION 10.82 | 48.57 years STANDARD_DEVIATION 10.34 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment India | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 21 Participants | 43 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Assess the Increase in Nurses Work Load
Investigators will assess nursing workload by frequency of filling of humidifier chamber.
Time frame: At baseline just before intubation and 24 hours from time of ICU admission
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heated Humidifier Group | Assess the Increase in Nurses Work Load | 0.0 time of refilling of nebuliser chamber | Standard Deviation 0 |
| Mist Humidifier Group | Assess the Increase in Nurses Work Load | 3.5 time of refilling of nebuliser chamber | Standard Deviation 0.99 |
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
Time frame: At baseline just before intubation and 24 hours from time of ICU admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heated Humidifier Group | Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume | 8.81 percentage change of ET tube volume | Standard Deviation 6.35 |
| Mist Humidifier Group | Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume | 14.08 percentage change of ET tube volume | Standard Deviation 6.66 |