NCT02780765

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 20, 2018

Completed
Last Updated

September 20, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

May 11, 2016

Results QC Date

April 26, 2018

Last Update Submit

August 21, 2018

Conditions

Cancer of Head and Neck

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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.

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.

Device: mist humidifier

Interventions

heated humidifierDEVICE

30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)

Heated humidifier group
mist humidifierDEVICE

30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier

Mist humidifier group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anaesthesiologists (ASA) 1 and 2 adult Patients
  • Undergoing surgery for head and neck cancer
  • Requiring overnight endotracheal tube \& breathing spontaneously

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Results Point of Contact

Title
Dr Vijaya Patil
Organization
Tata Memorial Hospital, Mumbai
vijayappatil@yahoo.com
+91-2224177000

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor and Anaesthetist

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 23, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

September 20, 2018

Results First Posted

September 20, 2018

Record last verified: 2018-08