Cancer of Head and NeckNCT02780765
Study to Compare the Effect of Two Different Types of Humidifier on the Endotracheal Tube Patency
A study testing heated humidifier and mist humidifier in people with Cancer of Head and Neck, run by Tata Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- heated humidifier and mist humidifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) 1 and 2 adult Patients
- Undergoing surgery for head and neck cancer
- Requiring overnight endotracheal tube \& breathing spontaneously
Who cannot join
- Patients with major cardiac diseases( coronary artery disease, Valvular diseases)
- Patients having gross chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, cystic fibrosis.
- Smokers(abstinence period less than 3 months)
- Patient in drugs having sialogogue properties.
- Patient on drugs having anti-sialogogue properties
About this study
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.
Read the 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.
- Conditions
- Cancer of Head and Neck
- Being tested
- heated humidifier, mist humidifier
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heated humidifierDevice
30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)
mist humidifierDevice
30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: heated humidifier |
| 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. Receives: Device: mist humidifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At baseline just before intubation and 24 hours from time of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vijaya P Patil, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780765
- Sponsor's protocol ID
- 1665
- Status last verified
- Aug 2018
- First submitted
- 11 May 2016
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare the Effect of Two Different Types of Humidifier on the Endotracheal Tube Patency
- ClinicalTrials.gov ID
- NCT02780765
- Acronym / sponsor ID
- 1665
- Conditions
- Cancer of Head and Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Posted 20 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heated humidifier group | Experimental | Device: heated humidifier30 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 | Device: mist humidifier30 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologists (ASA) 1 and 2 adult Patients
- Undergoing surgery for head and neck cancer
- Requiring overnight endotracheal tube \& breathing spontaneously
Key exclusion criteria (5 listed)
- Patients with major cardiac diseases( coronary artery disease, Valvular diseases)
- Patients having gross chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, cystic fibrosis.
- Smokers(abstinence period less than 3 months)
- Patient in drugs having sialogogue properties.
- Patient on drugs having anti-sialogogue properties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heated humidifier30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH) | Device | Heated humidifier group |
| mist humidifier30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier | Device | Mist humidifier group |
Primary outcome
Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing heated humidifier and mist humidifier in people with Cancer of Head and Neck, run by Tata Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume (time frame: At baseline just before intubation and 24 hours from time of ICU admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.